MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-18 for INFUSE BONE GRAFT, XX-SMALL KIT 7510050 manufactured by Medtronic Sofamor Danek Usa, Inc..
[1394004]
It was reported that the patient suffered a metacarpal fracture while boxing. An orif was performed at the time. At an unk time post-op, a second surgery was conducted due to non union and plate fracture. During this procedure, rhbmp-2/acs was used around the non-union and also placed into the screw holes. The surgeon reports that he has subsequently seen several lytic lesions approximating half the width of the metacarpal at the sites of the screws. He reports seeing healing supra-cortically at the fracture site.
Patient Sequence No: 1, Text Type: D, B5
[8322903]
Products from multiple manufacturers were implanted during the procedure. Although it is unk if any of the devices contributed to the reported event, we are filing this mdr for notification purposes. 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 | 1030489-2009-01213 |
| MDR Report Key | 1565052 |
| Report Source | 05 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-11-19 |
| Date Mfgr Received | 2009-11-19 |
| Date Added to Maude | 2009-12-30 |
| 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 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, XX-SMALL KIT |
| Generic Name | INFUSE BONE GRAFT |
| Product Code | MPW |
| Date Received | 2009-12-18 |
| Model Number | NA |
| Catalog Number | 7510050 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2009-12-18 |