FDA Adverse Event
Other
Summary report: N
BIO-TRANSFIX IMPLANT, 5MM X 50MM
MDR report key: 534095
·
Received July 14, 2004
Report
- Report Number
- 1220246-2004-00049
- Event Type
- Other
- Date Received
- July 14, 2004
- Date of Event
- April 1, 2004
- Report Date
- June 22, 2004
- Manufacturer
- ARTHREX, INC.
- Product Code
- MNU
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE BIO-TRANSFIX IMPLANT BROKE IN HALF POST-OP. DEVICE WAS IMPLANTED DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE, PERFORMED IN 2002. PT EXPERIENCED LATERAL PAIN IN 2003. A MRI WAS PERFORMED IN 2004 AND THE SUBSEQUENT REVISION SURGERY OCCURRED THE FOLLOWING MONTH. PT WAS NOTED TO BE FULLY HEALED AT THE TIME OF THE PROCEDURE. FOLLOW-UP INFO OBTAINED 2 MONTHS LATER REVEALED A SATISFACTORY PT CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-TRANSFIX IMPLANT, 5MM X 50MM | ACL RECONSTRUCTION - GRAFT FIXATION DEVICE | MNU | ARTHREX, INC. | AR-1351LB | 27328 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other| R |