BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM SELF-TAPPING, HEXALOBE SCREW, 14MM (TI-6AI-4V ELI)

    MDR report key: 6666605 · Received June 26, 2017

    Report

    Report Number
    2027467-2017-00052
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    May 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE A TOTAL OF FOUR (4) TRESTLE LUXE SCREWS CONTAINING TWO (2) SEPARATE IDENTIFYING NUMBERS UTILIZED IN THE CASE. BOTH ARE MANUFACTURED TO THE SAME LENGTH AND DIAMETER. THE DIFFERENCE BETWEEN THE TWO IS ONE IS A VARIABLE ANGLE & ONE FIXED ANGLE. IT IS UNKNOWN WHICH PART NUMBER/DESCRIPTION BELONGS TO THE FRACTURED/BROKEN SCREW: 71240-14; 4.0 MM VARIABLE ANGLE, SELF-DRILLING HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI), 71440-14; 4.0 MM FIXED ANGLE, SELF-DRILLING, HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI). MEDICAL RECORDS PROVIDED BY THE SALES REP STATE "THE CT SHOWS THE FRACTURED SCREW. IT HAS NOT BACKED OUT AND IS ALL IN BONE. THERE IS FUSION BONE WITHIN THE DISC SPACE. THE FACETS ARE LINED UP WELL". AN EVALUATION OF THE TRESTLE LUXE SCREWS IS NOT POSSIBLE AT THIS TIME. THE IMPLANT HAS NOT BEEN REMOVED FROM THE PATIENT NOR HAVE THE IDENTIFYING LOT NUMBER(S) BEEN PROVIDED.

    Description of Event or Problem · 1

    POST OP X-RAYS TAKEN (B)(6) 2017 REVEALED THE SCREW POSITIONED WITHIN THE LEFT C5 HAD FRACTURED AND BROKE. IT HAS NOT BEEN DETERMINED IF REVISION SURGERY IS NEEDED AT THIS TIME. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6), 2016 DURING AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447074 4.0MM SELF-TAPPING, HEXALOBE SCREW, 14MM (TI-6AI-4V ELI) SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other