MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2011-02-18 for INFUSE BONE GRAFT manufactured by Medtronic Sofamor Danek Usa, Inc.
[1841380]
It was reported in the literature article that a study of two prospective randomized clinical studies was conducted on patients with open tibial fractures. Patients were divided into two subgroups. The first subgroup consisted of 131 patients with gustilo-anderson type iiia or iiib open tibial fractures. The second subgroup consisted of 113 patients treated with reamed intramedullary nailing. Treatment options included an absorbable collagen sponge impregnated with rhbmp-2. The rhbmp-2 was placed over the fracture at the time of wound closure. One patient with gustilo-anderson type iii open fracture received bone graft (there was a non-union and additional graft was needed).
Patient Sequence No: 1, Text Type: D, B5
[8833737]
This report is a duplicate that was already reported under the clinical study for (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9094592]
Literature citation. Swiontkowski, m. , et al. "recombinant human bone morphongenic protein-2 in open tibial fractures: a subgroup analysis of data combined from two prospective randomized studies. " the journal of bone and joint surgery (2006); 88-a number 6: 1258-1265. (b)(4) - (secondary surgery). A review of the device history records was not possible without additional device information. Neither device nor applicable imaging studies were provided to the manufacturer for evaluation. The cause of the reported event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2011-00158 |
| MDR Report Key | 1996565 |
| Report Source | 03,05 |
| Date Received | 2011-02-18 |
| Date of Report | 2011-01-20 |
| Date Mfgr Received | 2011-01-20 |
| Date Added to Maude | 2011-02-18 |
| 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 | CHAD ASHTON |
| 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 | 2011-02-18 |
| 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. Required No Informationntervention | 2011-02-18 |