BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 14MM

    MDR report key: 2914694 · Received January 14, 2013

    Report

    Report Number
    1719045-2013-00108
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 18, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A 3.5MM CLAVICLE PLATE, AND FIVE SCREWS ON (B)(6) 2012 TO REPAIR A FRACTURED CLAVICLE. FIVE WEEKS POST OPERATION, THE PATIENT PRESENTED BREAKDOWN OF SKIN OVER THE SCREWS. THE BREAKDOWN OF SKIN PROGRESSED OVER A THREE DAY PERIOD TO THE POINT ONE SCREW HEAD WAS VISIBLE THROUGH A HOLE ON THE SKIN. THE PATIENT TESTED NEGATIVE FOR METAL ALLERGY. SURGERY FOR REMOVAL OF HARDWARE WAS ON (B)(6) 2012. THE CLAVICLE WAS HEALED, AND NO HARDWARE WAS IMPLANTED TO PLACE OF EXPLANTED HARDWARE. THIS IS 3 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20288 3.5MM CORTEX SCREW SELF-TAPPING 14MM SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, SCREWS