BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW, TI, 4.5 X 32MM

    MDR report key: 7713408 · Received July 24, 2018

    Report

    Report Number
    1220246-2018-00566
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    July 5, 2018
    Report Date
    July 24, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867124547
    PMA / PMN Number
    K141735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. A PORTION OF THE DEVICE REMAINS IN THE PATIENT AND THE REMAINING PORTION WAS NOT RETURNED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE FUSION CASE, THE HEAD OF THE SCREW AR-8545-32 POPPED OFF THE BASE OF THE SCREW. THE BASE OF THE SCREW REMAINS IN THE PATIENT. THE SCREW HAD ALREADY BEEN IMPLANTED; THE SURGEON WAS IMPLANTING ANOTHER SCREW; PER THE REP WHO WAS PRESENT, THE AR-8548-32 SCREW WAS IN THE COMPRESSION HOLE AND UNDER PRESSURE WHEN THE OTHER SCREW WAS BEING INSERTED. THE CASE WAS COMPLETED WITH NO ADDITIONAL INCISIONS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557608 LOW PROFILE SCREW, TI, 4.5 X 32MM PLATE, FIXATION, BONE HRS ARTHREX, INC. LOW PROFILE SCREW, TI, 4.5 X 32MM UNK1 00888867124547

    Patients

    Seq Age Sex Outcome Treatment
    1 Other