BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM X 22MM NON-TOGGLING CORTICAL SCREW

    MDR report key: 3832003 · Received February 4, 2014

    Report

    Report Number
    3025141-2014-00009
    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 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, 2.3MMX16MM LOCKING CORTICAL SCREW; 3025141-2014-00008:P/N CO-T2318-S 2.3MM X 18MM LOCKING 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
    73061 2.3MM X 22MM NON-TOGGLING CORTICAL SCREW SCRE, FIXATION, BONE HRS ACUMED LLC CO-N2322-S 223252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention