BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 400MM

    MDR report key: 1002523 · Received February 26, 2008

    Report

    Report Number
    2530088-2008-00004
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    July 1, 2007
    Report Date
    January 28, 2008
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K052151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    TWO 6.0MM TI HARD RODS 400MM, STATUS POST T9-T10 BURST FRACTURE, BROKE POSTOPERATIVELY. X-RAY REVEALED BOTH RODS BROKE IN HALF. BROKEN RODS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI HARD ROD 400MM RODS (SPINE) KWP SYNTHES BRANDYWINE NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention ALLOGRAFT/AUTOGRAFT| SCREWS| LOCKING CAPS| TRANSCONNECTOR