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 |