FDA Adverse Event
Malfunction
Summary report: N
ASCENSION PIP IMPLANT
MDR report key: 1626426
·
Received February 11, 2010
Report
- Report Number
- 1651501-2010-00002
- Event Type
- Malfunction
- Date Received
- February 11, 2010
- Date of Event
- August 26, 2009
- Report Date
- February 11, 2010
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- NEG
- PMA / PMN Number
- H010005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MFG RECORDS WERE REVIEWED AND NOTHING WAS IDENTIFIED TO INDICATE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. PRODUCT WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
A DR REPORTED THAT A PT WAS REVISED DUE TO A BOUTONNIERE DEFORMITY IN WHICH THE DR REMOVED THE IMPLANT AND REPLACED IT WITH A NEW IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP IMPLANT | FINGER PYROLYTIC CARBON PROSTHESIS | NEG | ASCENSION ORTHOPEDICS, INC. | PIP-200-40D | 07-0210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |