BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 400MM

    MDR report key: 2023864 · Received March 14, 2011

    Report

    Report Number
    2530088-2011-00056
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 22, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K090605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST CONSTRUCT IMPLANTATION, (B)(6) 2010, RETURNED TO SURGEON FOR POST OP VISIT. AN X-RAY ON (B)(6) 2011 SHOWED TWO RODS BROKE BILATERALLY BETWEEN L3 L5. THE CONSTRUCT WAS T-10 PELVIS. SURGEON REMOVED THE TWO RODS AND REVISED THE PATIENT WITH PARALLEL CONNECTORS ON EACH SIDE. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.0MM TI HARD ROD 400MM RODS AND BARS NKB SYNTHES BRANDYWINE N NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCREW