MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-03-21 for UNK manufactured by Unk.
[607116]
The pt had a quadricep tendon rupture sutured in 2006. Two months later, the pt returned with a recurrent tendon rupture, the physician noted that the pt had been non-compliant with brace use. Repair was reinforced with an external fixator. The following year, the pt stated he stood up and heard a "pop" and the pin site started bleeding. The pt was taken to the or and underwent removal and replacement of a tibial pin due to loosening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 831877 |
| MDR Report Key | 831877 |
| Date Received | 2007-03-21 |
| Date of Report | 2007-03-20 |
| Date of Event | 2007-01-04 |
| Report Date | 2007-03-20 |
| Date Reported to FDA | 2007-03-20 |
| Date Added to Maude | 2007-03-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | SELF-DRILLING 5MM PIN |
| Product Code | HXY |
| Date Received | 2007-03-21 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 819219 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-21 |