BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM TI PANGEA POLYAXIAL

    MDR report key: 1021899 · Received March 28, 2008

    Report

    Report Number
    2530088-2008-00013
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 6, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K052123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT STATUS POST L1 - L5, SECONDARY TO KYPHOSIS. SURGEON DETERMINED GREATER DECOMPRESSION REQUIRED. PERFORMED T6-L5 POST-OPERATIVELY. PT HEARD A POP POST-OPERATIVELY AND AN X-RAY WAS TAKEN, SHOWING THE 6.0MM TI HARD ROD 500MM DISENGAGED FROM THE PANGEA POLYAXIAL SCREW. THE PANGEA POLYAXIAL SCREW AND THE PANGEA LOCKING CAP REMAIN INTACT. SURGEON WILL NOT REMOVE IMPLANTS. THE SCREW IS THE MOST INFERIOR SCREW ON THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8.0MM TI PANGEA POLYAXIAL PANGEA POLYAXIAL SCREWS KWP SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOCKING CAPS| RODS