BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CERVICAL PLATE ASSEMBLY, 2 - LEVEL, 37MM

    MDR report key: 3193327 · Received June 27, 2013

    Report

    Report Number
    2027467-2013-00018
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE IS NOT POSSIBLE. THE IDENTIFYING LOT NUMBER HAS NOT BEEN PROVIDED. THE TRESTLE LUXE SCREW REMAINS ANCHORED WITHIN THE PATIENTS CERVICAL SPINE. UPON THE RECEIPT OF 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. IT IS INTENDED FOR USE IN THE ANTERIOR CERVICAL SPINE (C2-C7). A PRIMARY FEATURE OF THE TRESTLE PLATING SYSTEM IS THE PROPRIETARY ZERO STEP SELF-LOCKING MECHANISM. WHILE ADVANCING THE SCREW, THE BLOCKING SLIDE WILL MOVE MEDIALLY. WHEN THE SCREW IS FULLY INSERTED AND THE SCREWDRIVER REMOVED, THE BLOCKING SLIDE WILL RETURN TO THE CENTER POSITION. THE SURGICAL TECHNIQUE (LIT-84315) INSTRUCTS THE USER TO ADVANCE THE SCREW UNTIL THE HEAD OF THE SCREW IS FULLY SEATED INTO THE PLATE AND THE BLOCKING SLIDE IS POSITIONED OVER THE HEAD OF THE SCREW. THE SUPPLIED INSTRUCTIONS FOR USE STATE (INS-048); INTRAOPERATIVE MANAGEMENT: 5. 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 BONE SCREWS. HOLE PATTERNS ANGLED BEYOND 9 DEGREES MAY PROHIBIT PROPER SEATING OF THE BONE SCREWS.

    Description of Event or Problem · 1

    A PATIENT RETURNED FOR A SCHEDULED SIX WEEK POST-OP VISIT ON (B)(6) 2013. X-RAYS TAKEN AT THE TIME DISCOVERED ONE OF THE TRESTLE LUXE SCREWS LOCATED AT THE BOTTOM OF THE CONSTRUCT (C7 VERTEBRAE) WAS NO LONGER PROPERLY SEATED BENEATH THE PLATES LOCKING MECHANISM. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2013. THERE IS CURRENTLY NO PLANS FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292029 ANTERIOR CERVICAL PLATE ASSEMBLY, 2 - LEVEL, 37MM KWQ KWQ ALPHATEC SPINE INC 71002-037

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other