MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-07-15 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[15183376]
It was reported that 3 pts (5 fusion sites) who underwent high-risk, elective ankle and hindfoot fusions treated with rhbmp-2 augmentation went on to develop nonunion: 1 calcaneocuboid, 1 talonavicular, and 2 subtalar. Union was defined as a minimum of 50% bony bridging across the arthrodesis site, or multiple spot welding areas equaling 50% of the fusion site. Bone grafting was performed only to fill osseous defects and correct malalignment. It is stated that one of these pts is being followed for potential revision surgery but no other info was provided.
Patient Sequence No: 1, Text Type: D, B5
[15798538]
(b)(4). Pseudoarthrosis. Literature citation: bibbo, et al, recombinant bone morphogenetic protein-2 (rhbmp-21) in high-risk ankle and hindfoot fusions, foot & ankle international july 2009 number 7. A review of the device history records is not possible without add'l device info. Neither the device nor (test results or imaging films) were returned to the mfr for eval. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-00921 |
| MDR Report Key | 1764612 |
| Report Source | 03,05 |
| Date Received | 2010-07-15 |
| Date of Report | 2010-06-23 |
| Date of Event | 2009-01-01 |
| Date Mfgr Received | 2010-06-23 |
| Date Added to Maude | 2010-07-22 |
| 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 | 3 |
| 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 USA, INC. |
| Manufacturer Street | 4340 SWINNEA 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 | INFUSE BONE GRAFT |
| Product Code | MPW |
| Date Received | 2010-07-15 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 4340 SWINNEA RD. MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-07-15 |