BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANGORS POSTERIOR SYSTEM

    MDR report key: 1890167 · Received October 29, 2010

    Report

    Report Number
    9612420-2010-00004
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ULRICH GMBH & CO. KG
    Product Code
    NKB
    PMA / PMN Number
    K052385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED DEVICE WAS EXAMINED BY THE MANUFACTURER AND SHOWED NO IMPLANT FAILURE. THE PATTERN OF BREAKAGE WAS TYPICAL FOR A BURST FRACTURE. DEVICE WAS IN MANUFACTURER'S SPECIFICATIONS. ULRICH MEDICAL RECEIVED MORE INFORMATION FROM THE SURGEON. THE SURGEON STATED THAT IN THIS CASE HE TREATED A (B)(6) PATIENT (BODY MASS INDEX (B)(6)) WHO HAD A VERTEBRAL BODY FRACTURE IN L2 AND WAS STABILIZED FROM TH 12 UNTIL L4. THE SCREW BREAKAGE WAS CAUSED BY A PATIENT OVERLOAD NOT HAVING ENOUGH FUSION MASS DEVELOPED DUE TO POOR BONE QUALITY. THE IMPLANT ITSELF WORKED ACCORDING TO ITS SPECIFICATIONS. IMPLANT FAILURE IS ONE OF THE WARNINGS IN OUR INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    PEDICLE SCREW BREAKAGE AT L4 BOTH SIDES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGORS POSTERIOR SYSTEM NKB (MNH, MNI) NKB ULRICH GMBH & CO. KG WSA134558M1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention