FDA Adverse Event Injury Summary report: N

*

MDR report key: 129328 · Received October 17, 1997

Report

Report Number
129328
Event Type
Injury
Date Received
October 17, 1997
Date of Event
October 7, 1997
Report Date
October 15, 1997
Manufacturer
UNK
Product Code
KIG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PT HAD PAIN AND DEFORMITY OF LEFT WRIST. SURGERY DONE TO REPLACE SILASTIC WRIST IMPLANT. IMPLANT FOUND TO BE FRACTURED COMPLETELY AT DISTAL EXTENSION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * Implant SILASTIC WRIST IMPLANT KIG UNK UNK *

Patients

Seq Age Sex Outcome Treatment
1 61 YR Disability