BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHREX INC.

    MDR report key: 464718 · Received June 9, 2003

    Report

    Report Number
    1220246-2002-00004
    Event Type
    Other
    Date Received
    June 9, 2003
    Date of Event
    July 31, 2002
    Report Date
    September 25, 2002
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT L ROTATOR CUFF REPAIR MARCH 2002. ONE OF THE BIODEGRADEABLE IMPLANTS DISLODGED AND WAS PALPABLE UNDER THE SUBCUTANEOUS TISSUE. THIS WAS CAUSING THE PATIENT LIMITED RANGE OF MOTION. PATIENT RETURNED TO SURGERY IN 2002, AND UNDERWENT REMOVAL OF THE PALPABLE SCREW IMPLANT HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX INC. HEADED BIO-CORKSCREW MAI ARTHREX, INC. AR-1921B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other