FDA Adverse Event
Other
Summary report: N
TRUFIT BGS PLUG
MDR report key: 1160511
·
Received September 12, 2008
Report
- Report Number
- 1651491-2008-00013
- Event Type
- Other
- Date Received
- September 12, 2008
- Date of Event
- April 21, 2008
- Report Date
- July 30, 2008
- Manufacturer
- SMITH & NEPHEW INC.
- Product Code
- MQV
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
INITIAL SURGERY PERFORMED 2006 WITH TWO TRUFIT PLUGS IMPLANTED INTO THE LEFT MFC; 11MM AND 5MM PLUGS. PATIENT STARTED TO COMPLAIN OF PAIN POST-OP. MRI IN 2008 SHOWED INCOMPLETE HEALING OF ONE OF THE IMPLANT SITES. REVISION SURGERY APPROX FOUR MONTHS LATER; 11MM PLUG SITE APPEARED DEPRESSED WITH INCOMPLETE HEALING. REMOVAL OF SCAR TISSUE; DEFECT FILLED WITH TISSUE; NO CHALKY OR GUMMY MATERIALS IN SITE. A 9MM PLUG DEFECT CREATED; BLEEDING ON MEDIAL SIDE; SURGEON TREATED CHONDROMALACIA IN THE TROCHLEAR REGION WITH DEBRIDEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFIT BGS PLUG | TRUFIT | MQV | SMITH & NEPHEW INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |