FDA Adverse Event Summary report: N

ARTHREX

MDR report key: 2756147 · Received September 19, 2012

Report

Report Number
MW5027001
Date Received
September 19, 2012
Date of Event
August 28, 2012
Report Date
September 10, 2012
Manufacturer
ARTHREX
Product Code
MAI
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

EXPIRED DEVICE, MINI BIO PUSH LOCK ARTHREX IMPLANTED IN RIGHT WRIST. REASON FOR USE: TENDER SUBLUXING EXT CARPI ULNARIS. EXPIRED DEVICES IMPLANTED ON (B)(6) 2012. DEVICES EXPIRED ON 07/2012 AND 08/2012.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ARTHREX MINI PUSH BIOLOCK 2.5 MM X 8 MM MAI ARTHREX 349568
2 ARTHREX MINI PUSH BIOLOCK 2.5MM X 8MM MAI ARTHREX 328326

Patients

Seq Age Sex Outcome Treatment
1 36 YR