MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-08-14 for INFUSE BONE GRAFT 7510200AUS manufactured by Medtronic Sofamor Danek Usa, Inc.
[15027148]
It was reported that the patient underwent a fusion surgery to treat adjacent level disease. The previous fusion was extended to the sacrum/iliac (l5-s1) using interbody devices, posterior fixation, and rhbmp-2/acs. The patient did not fuse at l5-s1, and required a revision surgery 133 days post-op, to re-attempt to fusion of l5-s1.
Patient Sequence No: 1, Text Type: D, B5
[15275285]
This part is not approved for use in the united states; however a like device catalog # 7510200, product code nek was cleared in the united states. (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
| Report Number | 1030489-2012-01372 |
| MDR Report Key | 2696186 |
| Report Source | 01,05 |
| Date Received | 2012-08-14 |
| Date of Report | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Date Added to Maude | 2012-08-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HUZEFA MAMOOLA |
| 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 | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET |
| Product Code | NPZ |
| Date Received | 2012-08-14 |
| Model Number | NA |
| Catalog Number | 7510200AUS |
| Lot Number | UNK |
| ID Number | NA |
| 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. Required No Informationntervention | 2012-08-14 |