BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI PANGEA POLYAXIAL SCREW

    MDR report key: 1111014 · Received August 12, 2008

    Report

    Report Number
    2530088-2008-00044
    Event Type
    Injury
    Date Received
    August 12, 2008
    Report Date
    July 15, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K052123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L NARRATIVE: ADD'L INFO HAS BEEN REQUESTED. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED AT L2-L5 HAD A FOLLOW-UP X-RAY WHICH SHOWED THE HEAD OF A SCREW AT L5 HAD DETACHED FROM THE CONSTRUCT. PATIENT WAS RETURNED TO THE OR FOR REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.0MM TI PANGEA POLYAXIAL SCREW PANGEA POLYAXIAL SCREWS KWP SYNTHES BRANDYWINE NA 5275809

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention