BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTER, STRAIGHT, SS

    MDR report key: 2450713 · Received February 14, 2012

    Report

    Report Number
    2027467-2012-00005
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 24, 2012
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NOVEL STRAIGHT INSERTER IS PART OF THE NOVEL SPINAL SPACER SYSTEM. IT IS INTENDED TO ADVANCE/ DELIVER THE IMPLANT INTO THE DESIRED POSITION. PREVIOUS TESTING FOUND THAT THIS TYPE OF FAILURE IS THE RESULT OF EXCESSIVE LATERAL BENDING IN ORDER TO MANIPULATE THE IMPLANT INTO FINAL POSITION. THE TESTING ILLUSTRATED THAT FORCES REQUIRED TO FRACTURE THE ASSEMBLY ARE WITHIN THE CAPACITY OF THE SURGEON STRENGTH. IN ORDER TO REDUCE THIS TYPE OF OCCURRENCE THE INSERTER HAS BEEN REDESIGNED STRENGTHENING THE CONNECTION AND BETTER DISTRIBUTING THE LOAD AMONG THE SUPPORTING STRUCTURES. THE INTERNATIONAL CUSTOMER REPORTED THE PATIENT SUFFERED NO ILL EFFECT.

    Description of Event or Problem · 1

    THE TIP OF A NOVEL INSERTER FRACTURED AND BROKE AWAY FROM THE INSTRUMENT DURING SURGERY. THE THREADED SECTION REMAINS ENTRAPPED WITHIN THE SPINAL SPACER IMPLANTED IN THE PATIENT. THERE ARE NO PLANS TO REMOVE THE FOREIGN BODY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTER, STRAIGHT, SS LXH LXH ALPHATEC SPINE INC 64634-01 51015-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other