D
Patient 1
SURGEON EXAMINED X-RAY OF PATIENT POST-OP AND THOUGHT IMPLANT WAS BROKEN, BUT WAS MISTAKEN. REVISION SURGERY WAS PERFORMED TO REPOSITION THE SAME IMPLANT.
MAUDE MDR 1023755
- MDR report key
- 1023755
- Report number
- 1651501-2008-00009
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-02-11
- Date received
- 2008-03-24
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LYNN FERGUSON
- Address
- 8700 CAMERON RD., STE. 100 AUSTIN TX 78754 US
- Phone
- 512-512-5128
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | TOTAL FINGER JOINT IMPLANT | ASCENSION ORTHOPEDICS, INC. | KWF | PIP-200 | PIP-200-20D | 07/0407 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-03-24 | 0 | 1. O |
Event Narratives#
N
Patient 1
REVISION SURGERY WAS NOT THE RESULT OF IMPLANT FAILURE, BUT SURGICAL TECHNIQUE ERROR. DEVICE WAS NOT REMOVED.