BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10299814 · Received July 20, 2020

    Report

    Report Number
    3006742481-2019-00004
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    November 19, 2019
    Report Date
    December 16, 2019
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HRS
    UDI-DI
    00841506101514
    PMA / PMN Number
    K182492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOOK PLATE DETACHED FROM THE GEMINUS PLATE AS SEEN IN FLUOROSCOPY. DEVICES INVOLVED IN THIS PRODUCT COMPLAINT WERE NOT RETURNED FOR ANALYSIS. RECORDS REGARDING HOOK PLATE, HPE SCREW AND GEMINUS PLATE FROM THE LAST THREE LOTS MANUFACTURED WERE REVIEWED. THEY WERE FOUND TO MEET OUR SPECIFICATIONS. NO OTHER PRODUCT COMPLAINT ASSOCIATED WITH THIS TYPE OF FAILURE MODE, "HOOK PLATE DETACHED AFTER PROCEDURE COMPLETION" HAVE TAKEN PLACE IN THE LAST 12 MONTHS. THE ROOT CAUSE ASSOCIATED WITH THIS PRODUCT COMPLAINT APPEARS TO BE A COMBINATION OF GEMINUS PLATE NOT PROPERLY POSITIONED AND HPE SCREW NOT FULLY SECURED. THERE IS NO CONCERN REGARDING PRODUCT IN THE FIELD OR INVENTORY BELONGING TO THE SAME HOOK PLATE AND HPE SCREW LOT NUMBER. NO FACTS OR EVIDENCES WERE FOUND TO CLASSIFY THIS PRODUCT COMPLAINT AS DESIGN OR MANUFACTURING RELATED. NO INFORMATION WAS GIVEN ON WHAT THEY DID WITH THE BROKEN PIECE AND/OR REVISION OF SURGERY.

    Description of Event or Problem · 1

    A SURGEON WILL BE REVISING THIS DISASSOCIATED HOOK PLATE FROM THE GEMINUS PLATING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763928 SKELETAL DYNAMICS GEMINUS HOOK PLATE HRS SKELETAL DYNAMICS GEMINUS Hook Plate 00841506101514

    Patients

    Seq Age Sex Outcome Treatment
    1 Other