BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI PANGEA POLYAXIAL

    MDR report key: 1033329 · Received April 23, 2008

    Report

    Report Number
    2530088-2008-00019
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K052123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT FUSED 2 LEVELS WITH PANGEA SYSTEM. PT COMPLAINED OF PAIN. REVISION SURGERY REVEALED ENTIRE PANGEA SYSTEM WAS LOOSE. SURGEON NOTED THAT HEADS OF TWO OF THE SCREWS WERE OFF. THE TWO HEADS WERE SITTING ABOVE THE SCREWS, NOT FREE FLOATING. THE SURGEON REMOVED ALL HARDWARE AND REPLACED WITH ANOTHER PANGEA SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI PANGEA POLYAXIAL PANGEA POLYAXIAL SCREWS KWP SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| LOCKING CAPS| RODS