BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVEL LUMBAR INSERTER ASSEMBLY (STAINLESS STEEL)

    MDR report key: 4918933 · Received July 16, 2015

    Report

    Report Number
    2027467-2015-00149
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    September 23, 2013
    Report Date
    June 12, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. AN EVALUATION OF THE RETURNED NOVEL INSERTER REVEALED THE INNER SHAFT HAD FRACTURED AND BROKE AT THE THREADED DISTAL TIP. THE FRACTURE IS FLUSH WITH THE DISTAL TIP OF THE INSERTER TUBE, WHICH HOUSES THE INNER SHAFT. A PREVIOUS INVESTIGATION FOR THIS TYPE OF EVENT FOUND THAT AN EXCESSIVE LATERAL LOAD WAS PLACED ON THE TITANIUM TRIAL WHICH CAUSED THE THREADED TIP TO SHEAR ALONG THE DISTAL TIP OF THE INSERTER TUBE.

    Description of Event or Problem · 1

    TIP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464173 NOVEL LUMBAR INSERTER ASSEMBLY (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 64920 6820701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other