BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 1875087 · Received October 14, 2010

    Report

    Report Number
    2520274-2010-00177
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 22, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS NOT EXPLANTED. SYNTHES IS UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER AND/OR THE DATE OF MANUFACTURE AS NO PRODUCT RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    PT STATUS POST POSTERIOR LUMBAR FUSION L2 TO S1 IMPLANTATION RETURNED TO SURGEON FOR TWO MONTH POST OP VISIT. AN X-RAY SHOWED THE SCREW HEAD PULLED OUT OF THE ROD WITH THE LOCKING CAP STILL IN PLACE AND THE SCREW HEAD ROTATED LEFT SIDE S1. SURGEON IS NOT REMOVING THE HARDWARE AT THIS TIME. SURGEON NOTED A 10NM TORQUE LIMITING RATCHET WAS USED TO TIGHTEN THE CONSTRUCT. THIS IS ONE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI ROD HSB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR BONE GRAFT| LOCKING CAP| SCREW