BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARFIX MENISCAL SCREW

    MDR report key: 204478 · Received December 31, 1998

    Report

    Report Number
    1222933-1998-00004
    Event Type
    Injury
    Date Received
    December 31, 1998
    Date of Event
    December 1, 1998
    Report Date
    December 30, 1998
    Manufacturer
    INNOVASIVE DEVICES, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROX 2 WEEKS POST OPERATIVELY, THE PT COMPLAINED OF SWELLING AND DISCOMFORT. A RE-OPERATION WAS PERFORMED AND THE DR FOUND THREE MENSICAL SCREWS HAD DISLODGED FROM THE MENISCUS. BECAUSE THE MENISCAL TEAR HAD HEALED SUFFICIENTLY, THE DR REPORTED THAT NO FURTHER REPAIR WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARFIX MENISCAL SCREW Implant MENISCAL REPAIR IMPLANT HWC INNOVASIVE DEVICES, INC. NA 12085

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention