BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPIX ALIF

    MDR report key: 3669066 · Received March 8, 2014

    Report

    Report Number
    1000432246-2014-00001
    Event Type
    Injury
    Date Received
    March 8, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MAX
    PMA / PMN Number
    K083798
    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 IMPIX ALIF CAGE IMPLANTED ON (B)(6) 2013, WAS NOT THE RESULT OF A PROBLEM WITH THE DEVICE, BUT RATHER THE ESTIMATION OF THE REQUIRED HEIGHT OF THE CAGE BY THE SURGEON DURING THE FIRST SURGERY. THE STABOLT LUMBOSACRAL PLATE 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 LOOSE. 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
    141374 IMPIX ALIF INTERBODY FUSION DEVICE MAX MEDICREA INTERNATIONAL 12 MM X 9°

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention