BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI PANGEA LOCKING CAP

    MDR report key: 1875059 · Received October 14, 2010

    Report

    Report Number
    2530088-2010-00153
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 22, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    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 DATE OF MFR AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW CANNOT BE REQUESTED.

    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 THREE OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI PANGEA LOCKING CAP LOCKING CAP NKB SYNTHES BRANDYWINE NA NI

    Patients

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