MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2015-07-03 for GRAFTON DBM A43105 manufactured by Osteotech. Inc.
[6019268]
It was reported that on (b)(6) 2012 the patient suffered a workplace injury. This injury required a necessary surgical procedure on (b)(6) 2012 performed by the patient's surgeon. Complications resulted from this initial surgery and resulted in further surgical procedures on (b)(6) 2012, (b)(6) 2012 and (b)(6) 2013. One or more of these surgeries involved products manufactured by medtronic. The patient diagnoses include but are not limited to (b)(6), suffered loss of voice, other throat problems and onycholysis. Per medical records, it was reported that on (b)(6) 2012 patient underwent 360 degree cervical fusion 2 level corpectomy in which rhbmp-2/acs was sued. (b)(6) 2012: patient with admitting diagnosis of corpectomy of c5 to t1. Post-op day 1 follow-up: c6-c7 spinal cord compression status post c7 corpectomy ; hyperlipidemia; acute kidney injury (b)(6) 2012: patient follow-up: severe cervical stenosis status post c5-c6 corpectomy, pain is uncontrolled; hyperlipidemia; accute kidney injury. (b)(6) 2012: patient follow-up: severe cervical stenosis status post c5-c6 corpectomy; hyperlipidemia-resolved; accute kidney injury- resolved. (b)(6) 2012: patient discharged to home. Discharge diagnosis indicates: severe cervical spinal stenosis with cold compressions status post c7 partial corpectomy, doing fine; post-op hypokalemia, resolved; post-op hoarseness of voice probably secondary to vocal cord paralysis (b)(6) 2012 patient underwent mri of thoracic spine with contrast. Impressions: abnormal cord signal at c1-c2, right sided. Uncertain etiology; extensive postsurgical changes c5-t1; mild apparent chronic narrowing of the canal at c7 and t1; no focal disc protrusions, abscess, or other acute process is demonstrated (b)(6) 2012 patient underwent incision and drainage posterior cervical would infection with wound vac. Patient was discharged home. (b)(6) 2013: the patient presented with post-op infection. Patient diagnosed with anemia. Patient received daptomycin. Patient was dis charged to home. (b)(6) 2013: the patient presented with primary diagnosis of unspecified disorder of skin and subcutaneous tissue. Patient diagnosed with picc line infection. (b)(6) 2013 patient underwent fluoroscopy of cervical spine for hardware removal. The c-arm was provided for fluoroscopic assistance. (b)(6)2013: the patient underwent ultrasonic renal evaluation. Impression: no anatomic lesion or obstruction in either kidney; somewhat thickened appearing renal cortices bilaterally which may reflect medical renal disease; incident note of splenomegaly; no focal abnormality seen at the distended urinary bladder (b)(6) 2013: patient discharged to home (b)(6) 2013: patient presented with a complaint of urinary obstruction and uti symptoms. Having difficulty emptying bladder.
Patient Sequence No: 1, Text Type: D, B5
[14146700]
(b)(6). (b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
[34564063]
Patient Sequence No: 1, Text Type: N, H10
[34564064]
It was reported that on: (b)(6) 2013: patient presented for follow up with mrsa post op wound infection cervical spine with hardware in place. Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea of presumed infectious origin. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. Patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implants, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implant, and graft rash and other nonspecific skin eruption other voice disturbance diarrhea. . Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implant, and graft rash and other nonspecific skin eruption diarrhea. . Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2013: patient was diagnosed with (b)(6) infection and inflammatory reaction due to nervous system device, implant, and graft rash and other nonspecific skin eruption urinary tract infection, site not specified unspecified constipation. . Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2013: patient presented with a complaint of urinary obstruction and uti symptoms. Having difficulty emptying bladder. Patient underwent general examinations, which showed positive results. Patient was diagnosed with infection and inflammatory reaction due to nervous system device, implant, and graft rash and other nonspecific skin eruption urinary tract infection, site not specified unspecified constipation. Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2013:patient was diagnosed with infection and inflammatory reaction due to nervous system device, implant, and graft urinary tract infection, site not specified unspecified constipation candidiasis of unspecified site. . Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2013: patient was diagnosed with infection and inflammatory reaction due to nervous system device, implant, and graft urinary tract infection, site not specified unspecified constipation, dermatophytosis of nail. . Assessments: (b)(6). Infection and inflammatory reaction due to nervous system device, implant, and graft. Rash and other nonspecific skin eruption other voice disturbance. On (b)(6) 2014: patient presented for follow-up.
Patient Sequence No: 1, Text Type: D, B5
[41327423]
.
Patient Sequence No: 1, Text Type: N, H10
[41327424]
It was reported that on : (b)(6) 2012 the patient presented to establish care for chronic problems. The patient complained of hypertension, diabetes mellitus, neuropathy. On (b)(6) 2012: the patient presented for orthopedic evaluation of back injury on (b)(6) and x-rays in office (b)(6). Assessments: multiple contusions, other specified sites of sprains and strains. On (b)(6) 2012 the patient was presented for office visit for general follow up. Assessments: other specified sites of sprains and strains. Active problem list: multiple contusions, other specified sites of sprains and strains, lipoma of other skin and subcutaneous tissue. On (b)(6) 2012: per medical records ominent c6-c7 disc protrusion that is extruded cephlad with marked central canal stenosis and partial bilateral lateral foraminal stenosis. On (b)(6) 2012 the patient presented for follow up of neck injury and diabetes mellitus. On (b)(6) 2012: the patient presented with diagnosis of spinal stenosis and underwent x-ray of cervical spine. Impression: abnormal configuration through the previously fused levels c5-t1. Patient underwent ct of cervical spine without contrast. Impression: abnormal configuration through the previously fused levels c5-t1. Patient presented for follow-up with ct scan which showed complete dislodgement of both plates anteriorly with loss of both height and anterior kyphosis. X-rays showed plate had shifted anteriorly with the implant with a kyphosis. Patient reported tingling and numbness in fingers and some interscapular pain. On (b)(6) 2012: the patient was status post anterior cervical discectomy , partial corpectomy and interbody fusion which underwent dislodgement. The patient was back for repair. The operative course was complicated by vocal cord injury. On (b)(6) 2012, the patient presented with diagnosis of right true vocal cord paralysis. On (b)(6) 2012, the patient presented with diagnosis of cord compression , s/p 360ࠃervical fusion , vocal cord paralysis. On (b)(6) 2012: patient presented for a follow-up from surgery plus to remove staples. On (b)(6) 2012: patient presented for meds refill and complained of pain from his wound on back. On (b)(6) 2012: postsurgical changes in the lower cervical to upper thoracic spine down to t1; questionable mild cord atrophy lower cervical and upper thoracic spine, no epidural abscess or other acute process, mild to moderate multilevel spondylosis. Patient was admitted to the facility with chief complaint of wound drainage. The patient has dysphagia the patient underwent x-ray which revealed displaced screw. The patient discovered the loose screw almost 3 weeks after his initial surgery. Impression: (b)(6) male with cervical disk disease, status post. Surgical intervention#2 with hardware insertion. The patient has dysphagia as well as vocal cord dysfunction. On (b)(6) 2012 the patient presented with chief complaint of wound drainage. Pre-operative diagnosis: wound infection, status post cer vical fusion with instrumentation both anterior and posterior. Procedure performed: opening of wound, washout, removal of fusion, maintenance of hardware using 1l of 3% betadine and 3l of bacitracin, placement of drains. Assessment: patient with hypertension, hyope rcholestrerolemia uncontrolled diabetes mellitus type 2 cervical spine stenosis secondary top herniated nucleus pulposus undergoing decompressive surgeries presents with a wound cellulitis status post cervical spine decompression surgery. On (b)(6) 2012 the patient presented for an office visit. Operative diagnosis: posterior neck wound/ infection. On (b)(6) 2012 the patient underwent radiological test of the chest and complaints of neck pain, (b)(6), ambulatory difficulty. Patient underwent xr of chest. Impression: right picc tip over the svc. On (b)(6) 2012: patient was discharged from the facility. On (b)(6) 2013: the patient presented with post op infection. On (b)(6) 2013: patient presented for office visit. On (b)(6) 2013, the patient presented for follow up visit. Following observations were made during her examination: - recent weight change ; chronic and frequent cough ; bad breath voice change ; swelling of feet, ankles or hands. Diarrhea; kidney stones and sexual disability. On (b)(6) 2013, per the medical records, the patient underwent cmp, drug screening, sedimentation rate rbc. On (b)(6) 2013: the patient presented for change of wound vac. Dressing, picc dressing. On (b)(6) 2013: patient came for follow-up. Wound still showed some hardware and was closing slowly. On (b)(6) 2013: patient was advised not to get the dressing wet. Patient wound vac. Dressing change. On (b)(6) 2013 the patient was presented for office visit. Assessments: hyperpotassemia. On (b)(6) 2013 the patient underwent x rays of the cervical spine. Findings: the anterior and posterior fusion at c5-c6-c7-t1 remains stable in appearance. The anterior plate, vertebral cages and posterior fixation plates all appear the same as before. Alignment through the area is anatomic. On (b)(6) 2013: pt presented with moderate dysphonia c/b highly variable raspiness. Videostroboscopy demonstrated immobile unilaterally. Acoustic and aerodynamic testing supported hypofunctional voice function. Trial therapy produced improved vocal quality and stability. Based on the results of this evaluation, the patient was expected to require voice therapy to make vocal improvement. On (b)(6) 2013, and (b)(6) 2015: the patient underwent x-ray of cervical spine, 2 views. Impression: u nchanged appearance of the cervical spine when compared to the prior examinations. On (b)(6) 2013 patient presented for office visit for dressing change. On (b)(6) 2013: patient went for an office visit. On (b)(6) 2013 the patient presented to the office for follow up due to chronic problems and to discuss concerns for low bp readings. Patient also wanted to discuss neuropathy in lower extremity that has worsened. The patient had 2 surgeries since his last visit. First plate let go / broke / crushed esophagus; - took out c5; - 3 weeks later infected with (b)(6)/ attached to metal; still open. On (b)(6) 2013 patient presented for an office visit. On (b)(6) 2013: the patient presented with shortness of breath and ambulatory difficulty. On (b)(6) 2013 patient presented for an office visit due to dysphonia. Impression: base on that day voice session, the prognosis for i mprovement at this time is good contraindications to the same include participation in home treatment > 70% compliance. On (b)(6) 2013: the patient presented with yellowed or black eschar tissue noted on wound at medial upper back of cervical spine base. On (b)(6) 2013 patient presented for an office visit due to muscular tension dysphonia, vocal fold paresis unilateral. The patient also underwent a second voice therapy session. On (b)(6) 2013: patient presented for an office visit due dysphonia. Impression: base on that day voice session, the prognosis for imp rovement at this time is good contraindications to the same include participation in home treatment > 70% compliance. On (b)(6) 2013: the patient presented for an office visit due to dysphonia. Impression: base on that dayvoice session, the prognosis for improvement at this time is good contraindications to the same include participation in home treatment > 70% compliance. On (b)(6) 2013: patient underwent x-ray of chest. Impression: evidence of prior surgical and left upper quadrant surgery, otherwise unremarkable. Patient underwent two views of chest pa and lateral. Impression: evidence of prior surgical and left upper quadrant surgery, otherwise unremarkable. On (b)(6) 2013: the patient underwent x rays of the chest. Patient presented with chief complaint of a closure of a wound that got infected after he had prior neck surgery. On (b)(6) 2013 the patient was presented for office visit. Impression: status post hardware removal after multiple prior cervical spine surgery that was complicated by wound infection for which he has been on antibiotic therapy for the last few months. History of cervical spinal stenosis from degenerative disc disease with prior cervical spine surgery as mentioned before. Type 2 diabetes mellitus. Dyslipidemia. Diabetic neuropathy. Acute renal failure versus chronic kidney disease, stage 3. The patient also underwent x rays of the cervical spine. On (b)(6) 2013 the patient underwent removal of spire plates and wound revision. Preoperative diagnosis: contaminated and exposed hardware posteriorly, cervical wound. On (b)(6) 2013 patient presented for an office visit due to muscular tension dysphonia, vocal fold paresis unilateral, dysphagia. Impression: base on that dayvoice session, the prognosis for improvement at this time is good contraindications to the same include participation in home treatment > 70% compliance (b)(6) 2013: patient presented for office visit. Patient presented for follow-up with wounds healing well and staples removed. On (b)(6) 2013: the patient reported infected hardware; cervical osteo; post op hardware removal; dysuria. On (b)(6) 2013: patient presented for follow-up with wounds healed. On (b)(6) 2013: the patient presented for therapeutic exercise and manual therapy sessions. Patient reported soreness and pain along cervical incision area. On (b)(6) 2013: the patient presented for initial physical therapy evaluation with medical diagnosis of cervical injury/stenosis. Assess ment: cervical injury. On (b)(6) 2013: patient presented for office visit for follow up on infected hardware cervical osteo; post op removal hardware. Patient complains of a yeast infection developed in his groin and pannus area. Assessment: infection and inflammatory reaction due to nervous system device, implant and graft. Urinary tract infection. Unspecified constipation. Candidiasis of unspecified site. On (b)(6) 2013: patient presented for office visit with diagnosis of displacement cervical disc without myelopathy. On (b)(6) 2013 the patient presented for follow up visit. On (b)(6) 2013: patient presented with medical diagnosis of spinal stenosis. On (b)(6) 2013: the patient presented with ambulatory difficulty. On (b)(6) 2013: the patient presented for therapeutic exercise and manual therapy sessions. Patient reported soreness. The assessment revealed muscle spasm to c-spine. Diagnosis: spinal stenosis in cervical region, cervicalgia. On (b)(6) 2013: the patient presented for an office visit. Diagnosis: displacement cervical disc without myelopathy. On (b)(6) 2013: patient presented for follow up visit. On (b)(6) 2013 the patient presented with concern for loss of finger nails. On (b)(6) 2013 the patient was presented for office visit with pain and spasm. Diagnosis: stenosis. The patient also reported difficulty in sleeping, lifting and carrying. On (b)(6) 2013: the patient reported the complaint of nail problem. He is experiencing bleeding, tenderness, oozing to finger nail beds. Assessments: neoplasm of uncertain behavior of skin. Current problem list: pain, venous insufficiency, loss of sensation, brachial plexus injury and median nerve dysfunction. The patient underwent biopsy of single skin lesion. On (b)(6) 2013 the patient was presented for office visit for evaluation of finger nail loss to the right and the left hands. On (b)(6) 2013: patient presented for an office visit for follow up and reviews of pathology results. Impressions: nail dystrophy and psoriasis. The patient underwent laser treatment administered to finger nails. On (b)(6) 2013 the patient was presented for office visit for phototherapy treatment. Impressions: nail dystrophy and psoriasis. The patient underwent narrow band light therapy. On (b)(6) 2013, the patient presented with chief complaint of tightness to bilateral upper traps. On (b)(6) 2013 the patient presented for follow up due to right ankle ulcer. On (b)(6) 2013 the patient presented for follow up. Interval history: nail loss. Ankle ulcer resolved. Blood sugar. Neck pain / stiffness. Hypertension. On (b)(6) 2013: patient presented for office visit with pain upper back. On (b)(6) 2014 patient had a telephonic call. On (b)(6) 2014: patient presented for follow-up with complaint of pain in feet getting worse. Assessment: cervical herniation. On (b)(6) 2014, the patient presented for office visit. Patient presented for follow-up and underwent flexion extension x-ray which showed no movement between the spinous processes however, t1 is not very visible. On (b)(6) 2014: patient presented for follow-up. On (b)(6) 2014: the patient presented for review of systems. Diagnosis: anterior cervical disc fusion c5-6; herniated nucleus pulpous c6, c7 treated with c6 and partial c7 corpectomy with corpectomy cage and anterior spine plate, repeated neck surgery, plate failure necessitating posterior stabilization; history of irrigation and debridement associated with (b)(6). Sensation testing: an appreciable diffuse numbness or decreased sensitivity was present in both hands primarily distal to proximal interphalangeal joints. On orthopedic examination ,pain in cervical region is noted. Palpation revealed moderate signs of tenderness and or/hypertonicity of the cervical and upper thoracic region bilaterally from c1 to t4 level. Patient reported problems and difficulties with activities of daily living. Diagnosis: displacement of cervical intervertebral disc without myelopathy. Examination of neck: the posterior scar is depressed and has healed irregularly. His rom is restricted especially sis to side, over the shoulders, but is not fixed. Patient presented for examination for determination of being able to get back to work or not. Diagnosis: anterior cervical disc fusion c5-c6, herniated nucleus pulposus c6, c7, treated with c6 and partial c7 corpectomy with corpectomy cage <(>&<)> anterior spine plate, repeated neck surgery, plate failure necessitating posterior stabilization, history of irrigation <(>&<)> debridement associated with (b)(6) infection. On (b)(6) 2014 the patient presented for an office visit. On (b)(6) 2014: patient presented for follow-up and med refill with complaint of cervical pain and pain to both hands. On (b)(6) 2015: as per progress notes infused bone graph found in patient's body that was done without patientconsent. Loss of all fingernails, had biopsy done by dermatologist. On (b)(6) 2015, (b)(6) 2014 the patient presented for an office visit. On (b)(6) 2015 : patient complains of pain to hands and back of neck and shoulder. Diagnosis : cervicalgia of cervical spine hnp complicated by infection. Onycholysis bilateral hands and bilateral hand neuropathy. The patient underwent radiological study of the cervical spine. Impression: stable post operative appearance. Patient has cervical hnp complicated by hardware infection and unable to perform overhead activities with arms, treatment led to ocycholysis of bilateral fingers/hands and neuropathy of bilateral fingers and hands. Unable to grasp and squeeze. On (b)(6) 2015 the patient presented for an office visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2246640-2015-00007 |
| MDR Report Key | 4889811 |
| Report Source | 04,CONSUMER |
| Date Received | 2015-07-03 |
| Date of Report | 2014-12-12 |
| Date of Event | 2012-12-27 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2015-07-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTON DBM |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2015-07-03 |
| Model Number | NA |
| Catalog Number | A43105 |
| Lot Number | OTSCT1200484035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOTECH. INC |
| Manufacturer Address | 201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-03 |