BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRESTLE

    MDR report key: 1028415 · Received April 11, 2008

    Report

    Report Number
    2027467-2008-00006
    Event Type
    Other
    Date Received
    April 11, 2008
    Date of Event
    March 3, 2008
    Report Date
    April 11, 2008
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K070681
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED PART(S) CONFIRMS THE COMPLAINT. A VISUAL INSPECTION OF THE PLATE AND THREE OF THE SCREWS AND CONDUCTED BY ENGINEERING ON 03/20/2008. THE EVALUATION CONFIRMED THE LOCKING MECHANISM HAD BEEN MANIPULATED AND THAT THE PLATE WAS BENT. ENGINEERING STATED "THIS PROBABLY OCCURRED DURING THE REVISION SURGERY WHEN THE IMPLANT WAS REMOVED, AND THAT THE SURGEON WAS MORE THAN LIKELY NOT USING THE INSTRUMENT FOR ITS INTENDED USE". THE INSTRUCTIONS FOR USE FOR THE TRESTLE CERVICAL PLATE SYSTEM ((B) (4)) STATES THAT: THE SURGEON SHOULD HAVE A COMPLETE UNDERSTANDING OF THE SURGICAL TECHNIQUE, DESIGN RATIONALE, INDICATIONS AND CONTRAINDICATIONS. AND IN THE INTRA-OPERATIVE MANAGEMENT SECTION: THE SURGEON MUST TAKE GREAT CARE TO PROPERLY POSITION BONE SCREW HOLES WHEN USING THE VARIABLE DRILL GUIDE AND SELF CENTERING AWL. EXCESSIVELY CONVERGING HOLE PATTERNS MAY PROHIBIT PROPER SEATING OF THE NONE SCREWS. HOLE PATTERNS ANGLED BEYOND 9 DEGREE MAY PROHIBIT PROPER SEATING OF THE BONE SCREWS.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP POST OPERATIVE VISIT, AN X-RAY REVEALED THAT A BOTTOM SCREW WAS BACKING OUT FROM THE 51MM CERVICAL PLATE IMPLANT AT ABOUT HALFWAY IN A THREE-LEVEL CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRESTLE TRESTLE ANTERIOR CERVICAL PLATING SYS KWQ ALPHATEC SPINE, INC. 61003-051 49652

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention