BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM X 18MM LOCKING CORTICAL SCREW

    MDR report key: 3832022 · Received February 4, 2014

    Report

    Report Number
    3025141-2014-00008
    Event Type
    Injury
    Date Received
    February 4, 2014
    Report Date
    January 10, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED SCREW WAS EXAMINED UNDER MAGNIFICATION. THE SCREW SHOWED SIGNS OF SLIGHT WEAR ON THE HEAD OF THE SCREW, CONSISTENT WITH USE OF A HEX DRIVER TO DRIVE THE SCREW INTO THE PLATE/BONE. THE THREADS ALSO SHOWED SOME SIGNS OF SLIGHT WEAR ON THE TAPER PORTION OF THE THREADS AND THE LOCKING THREAD AREA. THE WEAR SEEMS CONSISTENT WITH NORMAL WEAR ON THE SCREW. THE SCREW WAS FURTHER EXAMINED TO DETERMINE IF THE SCREW MET QUALITY INSPECTION CRITERIA; THE SCREW MET QUALITY INSPECTION CRITERIA. ADDITIONAL MDRS ASSOCIATED WITH EVENT: 3025141-2014-00007: P/N CO-T2316-S 2.3MM X 16MM LOCKING CORTICAL SCREW; 3025141-2014-00009: P/N CO-N2322-S 2.3MM X 22MM NON-TOGGLING CORTICAL SCREW.

    Description of Event or Problem · 1

    DURING SURGERY, THE CLAVICLE PLATE WAS IMPLANTED USING 10 SCREWS. APPROXIMATELY 2 MONTHS LATER, THREE OF THE SCREWS HAD BACKED OUT OF THE PLATE/BONE. THOSE THREE SCREWS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73039 2.3MM X 18MM LOCKING CORTICAL SCREW SCREW, FIXATION, BONE HRS ACUMED LLC CO-T2318-S 302150

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention