BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 014MM (TI-6AL-4V ELI, NITINOL)

    MDR report key: 5049710 · Received September 2, 2015

    Report

    Report Number
    2027467-2015-00176
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    August 3, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE TRESTLE LUXE PLATE WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. AN EVALUATION OF THE TRESTLE LUXE PLATE IS NOT POSSIBLE AT THIS TIME. THE IMPLANT HAS NOT BEEN RETURNED. UPON THE RETURN OF THE SUSPECT DEVICE AND/OR ADDITIONAL INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED. 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

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT WHILE TRYING TO LOCK THE TRESTLE LUXE SCREWS INTO THE PLATE, THE PLATES GOLD LOCKING MECHANISM BECAME DETACHED. ALL FOUR (4) SCREWS AND PLATE WERE REMOVED AND REPLACED CAUSING OVER A 30 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581070 ANTERIOR CERVICAL PLATE ASSEMBLY, 1-LEVEL, 014MM (TI-6AL-4V ELI, NITINOL) KWQ KWQ ALPHATEC SPINE INC 71001-014 691165

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR