BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT PLATE, 2.0MM

    MDR report key: 8172936 · Received December 18, 2018

    Report

    Report Number
    3004369035-2018-00010
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 18, 2018
    Manufacturer
    I.T.S. GMBH
    Product Code
    HRS
    UDI-DI
    09120034304354
    PMA / PMN Number
    K060156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CHECKED THE DEVICE HISTORY RECORD OF THE PLATE 21101-11 WITH THE LOT NO. 679/091758 AND NO DEVIATIONS WERE DETECTED. AS OF THE E-MAIL FROM OUR DISTRIBUTOR, THE SURGEON REQUESTED A PROXIMAL HUMERAL PLATE. BUT, DURING PROCEDURE THE SURGEON NOTICED THAT THE FRACTURE WAS NOT CLOSE TO JOINT AND IMPLANTED THE ONLY FURTHER AVAILABLE PLATE - STRAIGHT PLATE 2.0MM. ACCORDING TO THE TECHNIQUE GUIDE, THE 2.0MM STRAIGHT PLATE IS NOT INDICATED FOR SHAFT FRACTURES OF LARGE BONES SUCH AS HUMERUS, FEMUR AND TIBIA, SO WE ARE ABLE TO STATE THAT IS WAS AN OFF-LABEL USE.

    Description of Event or Problem · 1

    WE HAVE RECEIVED THE INFORMATION VIA E-MAIL FROM OUR DISTRIBUTOR THAT A STRAIGHT PLATE 2.0MM, 11-HOLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013052 STRAIGHT PLATE, 2.0MM STRAIGHT PLATE, 2.0MM, 11-HOLE HRS I.T.S. GMBH 21101-11 679/091758 09120034304354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention