BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABOLT ANTERIOR LUMBO-SACRAL PLATE

    MDR report key: 3669067 · Received March 8, 2014

    Report

    Report Number
    1000432246-2014-00002
    Event Type
    Injury
    Date Received
    March 8, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    KWQ
    PMA / PMN Number
    K121323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REMOVAL OF THE STABOLT LUMBOSACRAL PLATE IMPLANTED ON (B)(6) 2013, WAS NOT THE RESULT OF A PROBLEM WITH THE DEVICE, BUT RATHER THE BONE QUALITY OF THE PATIENT. B14031430 - 3 HOLE LUMBOSCRAL PLATE 14 MM X 130°. B14046525 - STABOLT SCREW SH8 6.5 X 25 MM. B14046530 - STABOLT SCREW SH8 6.5 X 30 MM. THE APIX ALIF CAGE THAT WAS INVOLVED IN THE SURGERY IS REPORTED ON MDR. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ONE STABOLT LUMBOSACRAL PLATE AND ONE IMPIX ALIF CAGE WERE EXPLANTED. THE REVISION WAS DUE TO L5/S1 FAILURE / NON-UNION BECAUSE OF A MISJUDGEMENT BY SURGEON AND SOFT PATIENT BONE. ONE SCREW OF THE STABOLT PLATE MOVED AND THE CAGE WAS SLIGHTLY LOSE. POSTERIOR FUSION EXTENDED DOWN TO S1 AND UP TO L5 (NO LONGER TO L2) USING EXPEDIUM. A NEW IMPIX ALIF 14 MM X 12° CAGE WAS IMPLANTED INSTEAD OF THE IMPIX ALIF 12 MM X 9°.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141501 STABOLT ANTERIOR LUMBO-SACRAL PLATE LUMBAR STABILIZATION DEVICE KWQ MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention