INFUSE BONE GRAFT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-19 for INFUSE BONE GRAFT manufactured by Medtronic.

Event Text Entries

[809885] In 2006, the pt underwent l5-s1 transforaminal lumbar interbody fusion with pedicle screw placement. A 12mm allograft capstone spacer packed with infuse rhbmp-2-medtronic- was placed into his l5-s1 disc space. The pt had a 500 ml blood loss for the procedure, preoperatively, the pt had a serum creatinine level of 0. 6 mg/dl and blood urea nitrogen -bun- level of 17 mg/dl. Postoperatively on day 2, the creatinine rose to a maximum of 1. 5 mg/dl and the bun to 47 mg/dl. Levels dropped and stabilized to a creatinine level of 0. 6 mg/dl and bun level of 35 mg/dl, responding to intravenous hydration. On postoperative day 1, the pt developed a 3-4 minute run of supraventricular tachycardia -svt- with a heart rate into the 150's that spontaneously resolved. Despite a fever of 101. 4 degrees fahrenheit, blood, urine, and sputum cultures did not show evidence of growth. The white blood cell count -wbc- during this febrile episode never exceeded 10. 9 k/cmm, which it reached on postoperative day 1. On postoperative day five, the pt was discharged to an acute rehabilitation facility. Second operation. The pt's fusion failed. At re-operation in 2007, the fusion construct was extended to s2, the pedicle screws were revised, and autologous bone graft but not rhbmp was used. The pt had a 2 l blood loss for the procedure and was transfused perioperatively. During this admission, but creatinine and bun levels remained within normal limits, reaching a maximum level of 1. 2 mg/dl and 19 mg/dl, respectively. On postoperative day 3, the pt developed a fever of 101 degrees fahrenheit. Blood, urine, and sputum cultures showed no evidence of growth. The wbc count during this febrile episode never exceeded 7. 4 k/cmm, which it reached on postoperative day 2. There were no episodes of svt. The pt was transferred to acute rehabilitation on postoperative day 5. Third operation. The second fusion also failed. On five and a half months later, we performed a re-exploration of the previous l5-s1 laminectomy defect, removing the ligamentum flavum, which was still partially intact. We also decorticated the interspace contralateral to the interbody graft and packed it with cancellous iliac crest autograft. We replaced the loose l5 and s1 pedicle screws with larger screws, and decorticated the transverse process of l5 and ala of the sacrum, packing the lateral spaces with cancellous iliac crest autograft wrapped in collagen and hydroxyapatite sponges soaked with rhbmp-2 -medtronic-. The pt had a 1. 5 liter blood loss for the procedure and rec'd four units of packed red blood cells and two units of fresh frozen plasma perioperatively. Preoperatively, the pt had a serum creatinine of 0. 8 mg/dl and bun level of 12 mg/dl. Both creatinine and bun increased to a maximum of 3. 2 mg/dl and 53 mg/dl on postoperatively day 7. A renal echogram was performed to determine the cause of acute renal failure; the echogram revealed normal kidneys and no evidence of hydronephrosis. Levels dropped and gradually stabilized with a return to a normal creatinine value of 1. 1 mg/dl and bun to 25 mg/dl at three months after surgery. On postoperative day 10, the pt developed svt with a heart rate in the 160's and hypoxemia, desaturating of 70%. His temperature was 101. 3 degrees fahrenheit, and he underwent blood, urine and sputum culture. Results from a swan-ganz catheterization demonstrated hyperdynamic cardiac function and low systemic vascular resistance consistent with sepsis. He was started on prophylactic antibiotics. Anticoagulation with heparin was initiated until a ventilation-perfusion -vq- scan could be performed to rule out a pulmonary embolus. Results of the vq scan demonstrated low probability for pulmonary embolism and the anticoagulation was stopped. After the first episode of fever, the patient intermittently developed both low and high grade fevers for a period of 3 weeks. Blood, urine, and sputum cultures were obtained multiple times that did not show evidence of growth. In addition, a transesophageal echocardiogram was performed and revealed a normal ejection fraction and trace pericardial effusion. The wbc count during these febrile episodes never exceeded 10. 6 k/cmm, which it reached on postoperative day 4. Because of the lack of growth on cultures, intermittent fevers, and occasional episodes of altered mental status and confusion, magnetic resonance imaging -mri- of the lumbar spine was performed to evaluate for a possible infectious source on postoperative day 14. The lumbar spine mri demonstrated no evidence for surgical site abscesses. A thin rim of enhancement adjacent to where the bone graft had been placed was evident on postcontrast mri. A repeat mri done on postoperative day 29 again showed no evidence of infectious pathology. Given the patients history of gout and an exacerbation of joint pain on postoperative day 4, the pt underwent aspiration of fluid from the knee and elbow. The synovial fluid was positive for uric crystals but no organisms grew on culture. This procedure was repeated two more times on postoperative days 13 and 19 with no evidence of growth. The patient was subsequently started on oral prednisone on postoperative day 31 for a second gouty exacerbation. The pt cont indued to have severe back pain limiting mobility for the first six postoperative weeks. He then was gradually able to increase his activity and was discharged to acute rehabilitation. The patient rec'd concomitant general endotracheal anesthesia, blood products and multiple medication at the time of both exposures in infuse. Dose or amount: 2006, 2007. Diagnosis or reason for use: augmentation lumbosacral fusion. Failed lumbosacral fusion. Event reappeared after reintroduction? Yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5006032
MDR Report Key1019988
Date Received2008-03-19
Date of Report2008-03-17
Date of Event2007-09-20
Date Added to Maude2008-04-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameINFUSE BONE GRAFT
Generic NameNONE
Product CodeNEK
Date Received2008-03-19
Lot NumberM115006AAA
Device Expiration Date2008-10-31
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key989524
ManufacturerMEDTRONIC

Device Sequence Number: 2

Brand NameINFUSE BONE GRAFT
Generic NameNONE
Product CodeLMN
Date Received2008-03-19
Lot NumberM110608AAC
Device Expiration Date2009-11-30
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No2
Device Event Key989525
ManufacturerMEDTRONIC


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening 2008-03-19

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