FDA Adverse Event
Other
Summary report: N
TWINFIX TI 2.8 ANCHOR W/ULTRABRAID
MDR report key: 2142348
·
Received January 4, 2007
Report
- Report Number
- 1219602-2007-00003
- Event Type
- Other
- Date Received
- January 4, 2007
- Date of Event
- November 15, 2006
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT BEING RETURNED FOR EVAL; THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED INCIDENT. (B)(4). (B)(4) 2007.
Description of Event or Problem · 1
MEDWATCH REPORT FROM USER FACILITY INDICATES REVISION SURGERY WAS NEEDED DUE TO RELATED HARDWARE FAILURE FROM PREVIOUS SURGERY ON (B)(6) 2005. A (B)(6) YEAR OLD MALE BASEBALL PLAYER WITH ASLA REPAIR OF LEFT SHOULDER. IN (B)(6) 2006, REQUIRED ADD'L SURGERY DUE TO DECREASED RANGE OF MOTION AND PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TWINFIX TI 2.8 ANCHOR W/ULTRABRAID | TWINFIX | MBI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7210595 | 50124685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |