BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

    MDR report key: 7237681 · Received February 2, 2018

    Report

    Report Number
    2027467-2018-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    August 1, 2016
    Report Date
    January 8, 2018
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ORIGINAL SURGERY ON (B)(6) 2016, ALPHATEC RECORDS INDICATE TWO (2) DISTINCTIVE STYLE SCREWS WERE IMPLANTED. FOUR (4) OF EACH DESIGN. THE QUANTITY OF EACH PART NUMBER/DESCRIPTION WHICH HAVE BEEN REPORTED BROKEN IS UNKNOWN. THE 71340-14; 4.0 MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI). THE 71540-14; 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI). AN EVALUATION IS NOT POSSIBLE AT THIS TIME. THE IDENTIFYING LOT NUMBER IS UNKNOWN AND HAS NOT BEEN PROVIDED. THE BROKEN SCREWS REMAIN IMPLANTED WITHIN THE PATIENT'S CERVICAL VERTEBRAE. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM IS A TEMPORARY DEVICE USED TO STABILIZE THE CERVICAL SPINE DURING BONE FUSION DEVELOPMENT. DEVICE IMPLANTS INCLUDE A RANGE OF PLATE SIZES AND BONE SCREWS TO PROVIDE THE VERSATILITY REQUIRED FOR THE SPECIFIC INDICATIONS NOTED. FIXATION IS ACHIEVED BY MEANS OF A RIGID PLATE THAT IS SURGICALLY ATTACHED TO THE SPINE WITH BONE SCREWS. IMPLANT PLATES ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (ASTM F136) AND NITINOL (ASTM F2063) AND THE BONE SCREWS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (ASTM F136). ALL DEVICE COMPONENTS ARE INTENDED FOR FIXATION/ATTACHMENT TO THE ANTERIOR CERVICAL SPINE ONLY. IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION.

    Description of Event or Problem · 1

    PATIENT WAS INVOLVED IN A WORK RELATED INCIDENT. HIT IN THE BACK OF THE HEAD WITH A STEEL I-BEAM. X-RAYS TAKEN AFTER THE INCIDENT REVEALED 6 OF 8 TRESTLE LUXE SCREWS HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83014 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other