FDA Adverse Event Other Summary report: N

ASCENSION PIP

MDR report key: 1350676 · Received January 2, 2009

Report

Report Number
1651501-2009-00002
Event Type
Other
Date Received
January 2, 2009
Report Date
January 2, 2009
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Product Code
KYJ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PIP PROXIMAL COMPONENT FRACTURED POST-OP. BOTH IMPLANTS WERE REMOVED AND A PMMA-SPHERE WAS USED AS A SPACER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ASCENSION PIP TOTAL FINGER JOINT IMPLANT KYJ ASCENSION ORTHOPEDICS, INC. PIP-200 UNK

Patients

Seq Age Sex Outcome Treatment
1 52 YR Other