BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTALOC ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 889107 · Received August 1, 2007

    Report

    Report Number
    2027467-2007-00010
    Event Type
    Other
    Date Received
    August 1, 2007
    Date of Event
    June 19, 2007
    Report Date
    August 1, 2007
    Manufacturer
    ALPHATEC SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K993513
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE PART DID NOT REVEAL ANY DEFECT ON THE DEVICE. THE REQUISITION FORM FROM THE IMPLANT SURGERY WAS OBTAINED WHICH AIDED IN DETERMINING THE CORRECT PART AND LOT NUMBER OF THE CERVICAL PLATE USED FOR THE INITIAL IMPLANT SURGERY. THE CERVICAL PLATE (B)(4), LOT NUMBER 605609C (MANUFACTURER DATE (B)(4) 2006) REMAINS IN THE PT. THE DEVICE HISTORY RECORD OF BOTH PARTS INVOLVED WERE REVIEWED. THE EVALUATION OF THE DEVICE HISTORY RECORDS DO NOT REVEAL ANY QUALITY CONCERNS. (B)(4) IS THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE IMPLANT SURGERY ON (B)(6) 2006. (B)(4) (A SALES REPRESENTATIVE PRESENT DURING THE REVISION SURGERY AND INITIAL REPORTER OF THE INCIDENT) CONTACTED (B)(4) BY PHONE AFTER THE REVISION SURGERY. MR (B)(4) EXPLAINED THAT DURING THE INITIAL IMPLANT SURGERY, THE LOCKING MECHANISM ON THE IMPLANT WAS MANIPULATED SEVERAL TIMES BY THE SURGEON. THE SCREW BACK-OUT DUE TO PLATE LOCKING MECHANISM FAILURE. THE SALES REPRESENTATIVE REPORTED THAT THE PLATE LOCKING MECHANISM WAS MANIPULATED SEVERAL TIMES. THIS WEAKENED THE LOCKING MECHANISM OF THE PLATE. THE WEAKENED LOCKING MECHANISM MAY HAVE CONTRIBUTED TO THE SCREW BACKING OUT OF THE CERVICAL PLATE. INFORMATION REGARDING THE WARNINGS FOR THE DELTALOC REVEAL ANTERIOR CERVICAL PLATE SYSTEM APPLICATION IS CONTAINED WITHIN THE PACKAGE INSERT (B)(4). THE ROOT CAUSE IS IDENTIFIED AS USER ERROR.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP POST OP VISIT, AN X-RAY REVEALED THAT A SCREW WAS BACKING OUT FROM THE CERVICAL PLATE IMPLANT. A REVISION SURGERY WAS PERFORMED ON THE PT TO REMOVE THE BACKED-OUT SCREW. DURING THE REVISION SURGERY PROCEDURE, THE SALES REPRESENTATIVE SAW THAT LOCKING MECHANISM ON THE CERVICAL PLATE WAS BROKEN. ONLY ONE LOCKING MECHANISM WAS BROKEN OUT OF (B)(4) THAT ARE PRESENT ON THE PLATE. THE SURGEON LEFT THE CERVICAL PLATE IN THE PT AND ONLY REMOVED THE SCREW. THE PT HAD ALREADY FUSED. THE DATE OF THE POST OPERATIVE VISIT TO THE DR IS UNK. THE DATE OF SCREW MIGRATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTALOC ANTERIOR CERVICAL PLATE SYSTEM DELTALOC REVEAL PLATE SYSTEM KWQ ALPHATEC SPINE INC. 69040-014 607188F

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention