BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH

    MDR report key: 2901756 · Received January 8, 2013

    Report

    Report Number
    2530088-2013-00022
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, 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

    PATIENT WAS IMPLANTED WITH ROD AND SCREW FIXATION FROM L2-S1 IN (B)(6) 2010, DUE TO INJURIES SUSTAINED IN A MOTORCYCLE ACCIDENT. PATIENT COMPLAINED OF PAIN ON AN UNKNOWN DATE. EXAM AND X-RAYS TAKEN ON AN UNKNOWN DATE REVEALED THAT THE RIGHT ROD WAS BROKEN, AND THE LEFT ROD HAD PULLED OUT OF THE S1 SCREW. ON (B)(6) 2012 PATIENT RETURNED TO THE OR, AND SURGEON REMOVED ALL HARDWARE. SURGEON ALSO DID A PEDICLE SUBTRACTION OSTEOTOMY TO HARVEST AUTOGRAFT. AUTOGRAFT AND ALLOGRAFT CHIPS WERE IMPLANTED TO TREAT THE NON-UNION FOUND AT L4-L5 AND L5-S1. PATIENT WAS RE-IMPLANTED WITH ROD AND SCREWS FROM L2-ILIAC CREST. THIS IS 10 OF 23 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9692 6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/45MM THRD LENGTH SCREW NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention RODS, SCREWS, LOCKING CAPS, TRANSCONNECTOR