BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINVATEC

    MDR report key: 271042 · Received March 22, 2000

    Report

    Report Number
    MW1018501
    Event Type
    Malfunction
    Date Received
    March 22, 2000
    Date of Event
    February 29, 2000
    Report Date
    March 15, 2000
    Manufacturer
    LI MEDICAL TECHNOLOGIES INC.
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANCHOR SNAPPED OFF INSERTER WHEN IT WAS BEING INSERTED. PROCEDURE: ROTATOR CUFF REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINVATEC ULTRAFIX ANCHOR KGS LI MEDICAL TECHNOLOGIES INC. 10282 218-99

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other