BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI PANGEA POLYAXIAL

    MDR report key: 1903449 · Received November 15, 2010

    Report

    Report Number
    2530088-2010-00194
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    October 25, 2010
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNI
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS 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.

    Description of Event or Problem · 1

    PATIENT STATUS POST CONSTRUCT IMPLANTATION RETURNED TO SURGEON FOR POST OP VISIT. AN X-RAY SHOWED THE ROD SLIPPED OUT OF THE SCREW HEAD WITH A LOCKING CAP IN PLACE AT L4, THE END OF THE CONSTRUCT. SURGEON REVISED THE PATIENT. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.0MM TI PANGEA POLYAXIAL PANGEA POLYAXIAL SCREWS MNI SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD| LOCKING CAP