FDA Adverse Event
Summary report: N
ARTHREX HEADED BIO-ABSORBABLE CORKSCREW
MDR report key: 403790
·
Received July 8, 2002
Report
- Report Number
- MW1025495
- Date Received
- July 8, 2002
- Manufacturer
- ARTHREX
- Product Code
- MBJ
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RPTR IS WRITING TO INFORM FDA OF SIGNIFICANT IMPLANT/MEDICAL DEVICE FAILURE ASSOCIATED WITH THE DEVICE: ARTHREX HEADED BIO-ABSORBABLE CORKSCREW, REF # AR-1921B (ORDER #), LOT # (EACH BX HAS ONE ASSIGNED TO IT.) MANY ORTHOPAEDIC SURGEONS THROUGHOUT THE COUNTRY HAVE EXPERIENCED A SIGNIFICANT FAILURE RATE WITH THIS DEVICE. RPTR DID NOTIFY THE ARTHREX CO. TO DATE, THEY HAVE PULLED THE PRODUCT FROM THE MARKET, HOWEVER, NO FORMAL RECALL AND THE CO HAS NOT ISSUED ADMISSION OF PRODUCT FAILURE. THESE PRODUCT FAILURES HAVE RESULTED IN AN APPROX 20% FAILURE RATE WITH RETURN TO SURGERY IN APPROX 11/55 PTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHREX HEADED BIO-ABSORBABLE CORKSCREW | BIO-ABSORBABLE | MBJ | ARTHREX | NA | VARIOUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |