MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-08-17 for INFUSE BONE GRAFT 7510800AUS manufactured by Medtronic Sofamor Danek Usa, Inc.
[20795282]
It was reported that the patient underwent a pedicle subtraction osteotomy (pso) at l3 in a posterior fusion t10-iliac using posterior instrumentation, peek interbody spacers, and rhbmp-2/acs. The case went really well and the patient was responding well to treatment. At an unknown time post-op, the patient deteriorated with symptoms including increased pain and decreased mobility. The patient was re-hospitalized and it was noticed on x-ray that at the level of the pso, there was a non-union. The patient underwent a revision surgery 91 days post-op. Neural monitoring was used during the revision surgery. The current status of the patient is not ideal. Following the surgery, the patient has significant bilateral leg numbness and weakness bordering on paraplegia. Hopes are held for a return to function however the reality is that this may not be the case. No screws or any hardware were placed incorrectly in the revision surgery, the poor result is said to be one of positioning and the instability of the spine.
Patient Sequence No: 1, Text Type: D, B5
[20966068]
This part is not approved for use in the united states; however, a like device catalog # 7510800, product code nek was cleared in the united states. (b)(4). Pseudoarthrosis; this part is not approved for use in the united states; however, a like device catalog # 7510800, pma # p000058 was cleared in the united states. A review of ap and lateral x-rays performed postoperatively show t12 to iliac fusion after pedicle subtraction osteotomy. Rods both broken at l3. Fusion is incomplete. The device was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the re ported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2012-01401 |
| MDR Report Key | 2704010 |
| Report Source | 01,05 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-07-18 |
| Date Mfgr Received | 2012-07-18 |
| Device Manufacturer Date | 2011-10-12 |
| Date Added to Maude | 2012-08-17 |
| 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 | MPW |
| Date Received | 2012-08-17 |
| Model Number | NA |
| Catalog Number | 7510800AUS |
| Lot Number | M111059AAE |
| ID Number | NA |
| Device Expiration Date | 2014-01-01 |
| 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 | 2012-08-17 |