BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM

    MDR report key: 3203728 · Received July 3, 2013

    Report

    Report Number
    2520274-2013-03925
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K963172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND 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

    DURING A PROCEDURE THE SURGEON WAS IMPLANTING A 4.5MM CANNULATED SCREW INTO THE PEDICLE AND THE THREADS OF THE SCREW BEGAN TO UNWIND. THE SURGEON BACKED OUT THE SCREW. EVERYTHING WAS REMOVED. NO BROKEN PARTS REMAINED IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305520 4.5MM CANNULATED SCREW PARTIALLY THREADED/40MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR