FDA Adverse Event
Injury
Summary report: N
ASCENSION PIP
MDR report key: 1970365
·
Received January 14, 2011
Report
- Report Number
- 1651501-2011-00003
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- June 29, 2009
- Report Date
- January 14, 2011
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- NEG
- PMA / PMN Number
- H010005
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
VERY LITTLE INFO WAS SUPPLIED ABOUT THIS EVENT AND ATTEMPTS ARE BEING TAKEN TO OBTAIN ANY ADDITIONAL INFO. IF ANY ADDITIONAL INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF APPROPRIATE.
Description of Event or Problem · 1
A PT EXPERIENCED A DISLOCATION IN THE IMMEDIATE POST-OPERATIVE PERIOD. A REVISION SURGERY FOR STABILIZATION. OVER TIME, THE JOINT PROGRESSIVELY SUBLUXED. IT WAS BECOMING UNCOMFORTABLE AND HAD MINIMAL MOTION FOR THE PT. THE PT ELECTED TO HAVE THE IMPLANT REMOVED AND THE JOINT FUSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | FINGER PYROLYTIC CARBON PROSTHESIS | NEG | ASCENSION ORTHOPEDICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| R |