BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5MM TI CANCELLOUS LOCKING SCREW

    MDR report key: 2100237 · Received May 16, 2011

    Report

    Report Number
    1719045-2011-00244
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 27, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWQ
    PMA / PMN Number
    K063158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT BEING SCHEDULED. UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST PLATE AND SCREW IMPLANT RETURNED TO SURGEON FOR ROUTINE FOLLOW-UP, PT WAS ASYMPTOMATIC WITH NO PAIN. FOLLOW-UP X-RAYS SHOWED TWO S1 SCREWS WERE BROKEN OFF IN THE BONE WITH NO SCREWS PROTRUDING FROM THE PLATE WITH A VENTRAL UPPER SACRAL DOME CORONAL CLEAVAGE FRACTURE, CONCOMITANT WITH A DELAYED UNION OR PENDING UNION. SURGEON SCHEDULING REMOVAL OF THE HARDWARE AND REVISE THE PT WITH PEDICLE SCREWS. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM TI CANCELLOUS LOCKING SCREW TI CANCELLOUS LOCKING SCREW KWQ SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR PLATE