FDA Adverse Event Other Summary report: N

ASCENSION PIP

MDR report key: 494335 · Received November 4, 2003

Report

Report Number
1651501-2003-00034
Event Type
Other
Date Received
November 4, 2003
Date of Event
October 1, 2003
Report Date
November 3, 2003
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Product Code
KWF
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE DEVICE THAT WAS IMPLANTED IN THE LEFT LONG FINGER PIP JOINT WAS REMOVED AND REPLACED WITH ANOTHER DISTAL COMPONENT OF THE SAME SIZE AND A PROXIMAL COMPONENT OF THE NEXT LARGER SIZE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ASCENSION PIP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. PIP-200 02-432

Patients

Seq Age Sex Outcome Treatment
1 56 YR Other