BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK

    MDR report key: 1556557 · Received December 7, 2009

    Report

    Report Number
    MW5013840
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 7, 2009
    Manufacturer
    JJH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MITEK SUPER INSERTER PRODUCT # 212513 BROKE OFF IN GLENOID OF SHOULDER DURING PLACEMENT OF SUPER ANCHOR. DATES OF USE: 2009. DIAGNOSIS: GREATER TUBEROSITY FRACTURE LEFT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK NONE LXH JJH SUPER

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR