BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDI PLATE

    MDR report key: 149339 · Received February 13, 1998

    Report

    Report Number
    1030489-1998-00003
    Event Type
    Injury
    Date Received
    February 13, 1998
    Date of Event
    December 18, 1997
    Report Date
    February 6, 1998
    Manufacturer
    SOFAMOR DANEK MFG.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE SIDE OF LDI PLATE AT T11 AND THE FIXATION SCREW CAME OFF FROM THE LDI VERTEBRAL IMPLANT. ADDITIONAL SURGERY WAS PERFORMED DECEMBER 18TH USING TSRH FROM POSTERIOR SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LDI PLATE Implant SPINAL FIXATION KWQ SOFAMOR DANEK MFG. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention