MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-29 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[125273232]
(b)(6) hospital, (b)(6). 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. Although it is unknown whether this 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
[125273233]
It was reported that the patient presented with the following pre-op diagnosis: l5-s1 spondylitic spondylolisthesis. She underwent the following procedures: l5-s1 gill decompression, posterior interbody fusion l5-s1, application of vertebral body fusion cage, l5-s1, posterolateral fusion l5-s1, posterior instrumentation l5-s1, allograft and local autograft bone grafting. As per the operative notes,? Patient was brought to the operating room and placed under general endotracheal anesthesia. Patient was transferred to the prone position on the operating table. The patient's back was prepped and draped in the usual sterile fashion. A posterior localizing x-ray was obtained. A posterior incision was made and carried down through skin and subcutaneous tissue to spinous process. The spinous process l5 was identified and the paraspinal musculature was stripped off of the spinous process of l4-5 and the sacrum out to the sacral ala and the transverse process of l5.? No intra-operative complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-01415 |
| MDR Report Key | 8013155 |
| Report Source | CONSUMER |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-29 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-10-29 |
| 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 | 2018-10-29 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-29 |