MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2015-01-05 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc.
[17292281]
It was reported in a literature article which compared the results of treating nonunion with either bone morphogenetic protein (bmp)-7 or bmp-2, that between 2001 and 2009, 214 limb segments were treated for nonunion with either bmp-7 or bmp-2. One hundred thirty eight limb segments (112 patients) received bmp-2. There were 45 tibiae, 43 femora, and 50 humeri treated. Eighty-eight percent (121 of 138 limb segments) received autograft and bmp-2, and 12% received bmp-2 only (14 limb segments) or allograft plus bmp-2 (3 limb segments). Twenty-nine percent of limb segments (40 of 138) were treated with an adjunctive external bone growth stimulator. Patients who had the bone stimulator were encouraged to use it as soon as they received it. Radiographic healing occurred in 129 (93%) of 138 limb segments at an average of 19 weeks (range, 2-53) after surgery. Eighty-eight percent of limb segments (122 of 138) were full weight bearing (clinically healed) at the completion of the study. The average time to weight bearing was 15 weeks (range, 0-53) after surgery. The average time to weight bearing was 15 weeks (range, 0-53) after surgery. The average followup was 17 months (range, 3-56). Thirty-two subjects, across both groups, had more than 1 surgical procedure for bone grafting. Seven patients (7 limb segments) received both bmp-7 and bmp-2 in the same limb segment during different surgical procedures. These 7 patients underwent treatment with bmp-7 and did not heal. They underwent treatment with bmp-2 at an average of 22 months (range, 6-57) after the initial treatment with bmp-7. After treatment with bmp-2, all patients healed at an average of 18 weeks (range, 10-22). The complication rate in the bmp-2 group was lower (9%) than in the bmp-7 group (17%). Ten patients in the bmp-2 group (9%) had an unspecified complication.
Patient Sequence No: 1, Text Type: D, B5
[17500500]
Literature citation: conway et al. ? Bmp-7 versus bmp-2 for the treatment of long bone nonunion?. Orthopedics. 2014; 37(12):e1049-e1057. (b)(6). (b)(4). Neither the device nor patient medical records were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Products from multiple manufacturers were implanted/used during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-00012 |
| MDR Report Key | 4381704 |
| Report Source | 03 |
| Date Received | 2015-01-05 |
| Date of Report | 2014-12-06 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2014-12-06 |
| Date Added to Maude | 2015-01-05 |
| 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, OSTEOIN |
| Product Code | MPW |
| Date Received | 2015-01-05 |
| 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 | 2015-01-05 |