BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK

    MDR report key: 116043 · Received June 27, 1997

    Report

    Report Number
    116043
    Event Type
    Injury
    Date Received
    June 27, 1997
    Date of Event
    May 9, 1997
    Report Date
    May 15, 1997
    Manufacturer
    MITEK SURGICAL PRODUCTS, INC.
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD ROTATOR CUFF REPAIR APPROX. 2 YEARS AGO AT ANOTHER FACILITY. REINJURED SHOULDER RECENTLY. MRI SHOWED MITEK SUTURE ANCHOR HAD 1 BROKEN WING AND BOTH THE WING AND THE SUTURE ANCHOR HAD MIGRATED. PT HAD EXPLORATION 5/9/97. BOTH WING AND SUTURE ANCHOR FOUND AND REMOVED. ROTATOR CUFF REPAIRED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK Implant SUTURE ANCHOR KGS MITEK SURGICAL PRODUCTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization