MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-03-06 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[137935561]
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. X-ray review results: post-op x-rays for thoraco lumbar sacral stabilization shows a unilateral rod fracture at the lumbo sacral transition. By report occurred, 24 months post-op fusion status is unknown, degree of deformity correction is unknown, but there appears to be partial collapse of the vertebra at this level. An interbody graft is also present here. Although it is unknown whether the product caused or contributed to the reported event, we are filling this mdr for notification purpose. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137935562]
It was reported that on: (b)(6) 2017: the patient was presented with the following pre-op diagnosis: l4 hemivertebrae with spine deformity associated with low back pain and radiculopathy. He underwent the following procedures: t10 to ileum arthrodesis using bmp allograft and autograft. L4 pedicle resection. L3/5 cage replacement. Kyphotix correction and derotation. Continuous intraoperative neuromonitoring with sseps, meps and emg. Operative findings: resection of the right l4 pedicle and placement of interbody cage. Good sagittal and coronal correction based on intraoperative fluoro at the end of the procedure. As per operative notes,? We tried several temporary spacers and decided to place a 14 mm x 26 mm cage, which provided the best fit based on lateral x-ray. The peek cage was then opened and packed with autograft bone. The cage was then placed under intermittent fluoro to confirm good orientation and proper position. A similar 5. 5 mm cobalt chrome rod was then placed on the left an set screw were placed. Final lateral and ap x-rays show good cage placement as well as good correction of the kyphotic and scoliotic deformity. Once we were satisfied with the cage placement and deformity correction, final tightening was performed. The incision was copiously irrigated before the arthrodesis was performed. Using the high-speed drill, we decorticated from t10 to the ileum and packed the posterolateral margins with bmp and mixture of allograft and autograft. A medium-medium drain was placed and secured to the skin". On (b)(6) 2017: patient presented for 6-week post-operative appointment after staged procedure for thoracolumbar scoliosis correction with l4 vertebrectomy. He had history of imperforate anus, colostomy with chronic back pain and leg pain and scoliosis. His rle radicular pain that he had immediately after surgery has dissipated. His primary area of pain is in his low back and buttock on the left side. On (b)(6) 2017: patient presented for 3 months post-operative appointment. He has noticed an increase in his lower back pain and some left leg symptoms since that decreased. On (b)(6) 2017: the patient was presented with the following pre-op diagnosis: lumbar scoliotic deformity s/p t10-ilium fusion, with hardware failure. He underwent the following procedures: exploration of prior thoracolumbar instrumented fusion on the right side. With removal and replacement of right sided fractured rod. Placement of new right sided satellite rod. Placement of second right iliac screw. Operative findings: right sided fractured rod removed and replaced with two new cobalt chromium rods. Second right sided iliac screw placed to reinforce construct. On (b)(6) 2017: patient presented for 6 weeks post-operative appointment after revision t10 to ilium fusion after fracture of right rod. He denies any significant lower extremity pain. In general, he feels as through he is making significant progress. On (b)(6) 2017: the patient underwent x-ray thoracolumbar spine ap lateral examination. Impression: no displacement of fixation hardware following instrumentation from t10 to posterior iliac. On (b)(6) 2018: the patient presented for a follow-up visit. Assessment: status post right fusion. Osteoarthritis of first metatarsophalangeal joint. On (b)(6) 2018: patient presented for 6 months post-operative appointment after revision t10 to ilium fusion after fracture of right rod. He feels as though he is somewhat improved compared to pre-op but is frustrated that the left buttock and thigh symptoms persist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2019-00225 |
| MDR Report Key | 8393522 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2019-03-06 |
| Date of Report | 2019-08-22 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Street | 4340 SWINEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NEK |
| Date Received | 2019-03-06 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-06 |