FDA Adverse Event Injury Summary report: N

TWINFIX TI 2.8 SUTURE ANCHOR

MDR report key: 2142345 · Received January 4, 2007

Report

Report Number
2142345
Event Type
Injury
Date Received
January 4, 2007
Date of Event
November 15, 2005
Report Date
November 14, 2006
Manufacturer
SMITH & NEPHEW
Product Code
MBI
Product Problem
Yes
Report Source
User Facility report
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

(B)(6) YEAR OLD MALE BASEBALL PLAYER WITH ALPSA REPAIR OF LEFT SHOULDER, IN (B)(6) 2005. IN (B)(6) 2006, REQUIRED ADD'L SURGERY DUE TO DECREASED RANGE OF MOTION AND PAIN. DR. (B)(6) MET WITH MANUFACTURER IN (B)(6) 2006.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TWINFIX TI 2.8 SUTURE ANCHOR * MBI SMITH & NEPHEW * 50124685
2 TWINFIX TI 2.8 SUTURE ANCHOR * MBI SMITH & NEPHEW * 50115594

Patients

Seq Age Sex Outcome Treatment
1 20 YR Required Intervention