BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK ANCHOR SYSTEM

    MDR report key: 8148 · Received May 18, 1994

    Report

    Report Number
    8148
    Event Type
    Malfunction
    Date Received
    May 18, 1994
    Date of Event
    May 11, 1994
    Report Date
    May 18, 1994
    Manufacturer
    MITEK SURGICAL PRODUCTS, INC.
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    WHILE MD WAS USING ANCHOR, UPON WITHDRAWAL OF THE INSTRUMENT, IT WAS NOTED THAT A PIECE OF THE INSERTER TIP WAS BROKEN.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other