FDA Adverse Event
Other
Summary report: N
BIO-TRANSFIX IMPLANT, 5MM X 50MM
MDR report key: 532723
·
Received July 6, 2004
Report
- Report Number
- 1220246-2004-00056
- Event Type
- Other
- Date Received
- July 6, 2004
- Date of Event
- March 6, 2004
- Report Date
- July 6, 2004
- Manufacturer
- ARTHREX, INC.
- Product Code
- MNU
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PT WAS OPERATED IN 2004 OF AN ACL RECONSTRUCTION. ELEVEN DAYS LATER THE IMPLANTS WERE TAKEN OUT DUE TO AN INFECTION. REFERENCE MDR REPORT # 1220246 2004 00057 FOR THE SECOND DEVICE INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-TRANSFIX IMPLANT, 5MM X 50MM | GRAFT FIXATION DEVICE (ACL RECONSTRUCTION) | MNU | ARTHREX, INC. | AR-1351LB | 39932 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other| R |