BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 034MM (TI-6AL-4V NITINOL)

    MDR report key: 4862518 · Received June 23, 2015

    Report

    Report Number
    2027467-2015-00089
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    July 26, 2013
    Report Date
    June 12, 2015
    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

    MDR BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW. VISUAL EXAMINATION OF THE TRESTLE LUXE PLATE FOUND ONE OF THE BLOCKING SLIDES HAD BECOME COMPLETELY DETACHED FROM THE IMPLANT. WITNESS MARKS ALONG BOTH THE ANTERIOR AND POSTERIOR SIDES OF THE PLATE ARE PRESENT AND REVEAL THE LOCATION OF THE INSTRUMENT TO PLATE DURING COUNTERING/BENDING. THE PLATE CONTAINS A SINGLE WITNESS MARK ON THE POSTERIOR SIDE DIRECTLY BEHIND THE LOCATION OF THE DETACHED BLOCKING SLIDE AND TWO WITNESS MARKS AT THE GRAFT WINDOW ON THE ANTERIOR SIDE. THE COMBINATION OF THESE WITNESS MARKS CONFIRMS THE PLATE BENDING INSTRUMENT WAS IMPROPERLY POSITIONED WHILE CONTOURING/BENDING THE PLATE. ALPHATEC SURGICAL TECHNIQUE (LIT-84315) PROVIDES INSTRUCTIONS AS TO PROPER PLATE CONTOURING. IT ALSO PROVIDES CAUTION TO REDUCE/ELIMINATE THE RISK OF THIS TYPE OF EVENT. CAUTION: DO NOT PLACE THE ANVIL PORTION OF THE PLATE BENDER OVER THE BLOCKING SLIDE AS DAMAGE CAN OCCUR AND AFFECT ITS FUNCTION. THE PROVIDED INSTRUCTIONS FOR USE (INS-048) STATE; INTRAOPERATIVE MANAGEMENT: TRESTLE LUXE ANTERIOR CERVICAL PLATES ARE CONTOURED TO CLOSELY MATCH THE ANATOMICAL CONFIGURATION OF THE SPINE. IF THE PLATE CANNOT BE FITTED AND ADDITIONAL CONTOURING IS NECESSARY, IT IS RECOMMENDED THAT SUCH CONTOURING BE MINIMAL AND BE PERFORMED WITH THE INSTRUMENTATION PROVIDED. THE PLATE MUST NOT BE CONTOURED IN PROXIMITY OF BONE SCREW POCKETS OR SCREW RETENTION MECHANISM. WHEN CONTOURING THE PLATE, GREAT CARE SHOULD BE TAKEN NOT TO SCRATCH, NOTCH OR DENT THE SURFACE AS SUCH DEFORMITIES MAY COMPROMISE THE STRENGTH OF THE IMPLANT.

    Description of Event or Problem · 1

    THE GOLD PIECE CAME OFF THE MIDDLE OF THE PLATE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406754 ANTERIOR CERVICAL PLATE ASSEMBLY, 2-LEVEL, 034MM (TI-6AL-4V NITINOL) KWQ KWQ ALPHATEC SPINE INC 71002-034 644150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other