BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE ANGLE SELF-DRILLING SCREW - 4.0MM X 14MM, TI

    MDR report key: 2492932 · Received March 15, 2012

    Report

    Report Number
    2027467-2012-00008
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE IS CURRENTLY BEING CONDUCTED. UPON COMPLETION A FOLLOW-UP SUBMISSION WILL BE PROVIDED. THE TRESTLE 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 AND 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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED THE TRESTLE SELF-DRILLING SCREW INDICATED THE DEVICE WAS PROPERLY MANUFACTURED AND RELEASED TO DESIGN SPECIFICATIONS. VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION DETECTED NO ANOMALIES.

    Description of Event or Problem · 1

    DURING A SCHEDULED ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) OF THE C4-C5 CERVICAL VERTEBRAE A PREVIOUSLY IMPLANTED TRESTLE SCREW WAS DISCOVER FRACTURED IN THE C5. THE SCREW WAS PART OF A CONSTRUCT WHICH REMAINED FROM THE PREVIOUS FUSION AT THE C5-C7. THE TRESTLE PLATING SYSTEM WAS REPORTED TO HAVE BEEN ORIGINALLY IMPLANTED APPROXIMATELY ONE YEAR PRIOR TO ITS DETECTION. THE TOP PROXIMAL SECTION OF THE SCREW WAS REMOVED WITHOUT ISSUE WHILE THE BOTTOM THREADED PORTION REMAINS ANCHORED IN THE PATIENTS VERTEBRAL BODY (C5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIABLE ANGLE SELF-DRILLING SCREW - 4.0MM X 14MM, TI KWQ KWQ ALPHATEC SPINE INC 61240-014 629177

    Patients

    Seq Age Sex Outcome Treatment
    1 Other