MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-07 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[129569626]
The 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 result: post-op x-ray for t12-l1 lateral discectomy and fusion with interbody graft is provided. Hardware placement is appropriate. There is no apparent hardware malfunction. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129569627]
It was reported per social media post (dated (b)(6) 2018) that on (b)(6) 2007, patient underwent spinal fusion using rhbmp-2/acs. Po st-operatively, the patient alleged unspecified injury due to the use of rhbmp-2/acs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2018-01614 |
| MDR Report Key | 8140933 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2018-12-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2018-12-07 |
| 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 | 2018-12-07 |