BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYLINE LARGE DIAMETER 14MM OVERSIZED SCREW

    MDR report key: 2842033 · Received November 21, 2012

    Report

    Report Number
    1526439-2012-00279
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 21, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    KWQ
    PMA / PMN Number
    K052552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT TREND ANALYSIS FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS PRODUCT CODES. NO LOT NUMBER OR SAMPLE WAS AVAILABLE. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS-FUNCTIONAL REPRESENTATION FROM RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    SURGEON REPORTED A REVISION ACDF CASE WITH A PATIENT THAT HE IMPLANTED THE SKYLINE 40MM PLATE AND SCREW. THE SURGEON INDICATED THE SCREW HAD BACKED OUT OF THE PLATE PAST THE CAM LOCKING MECHANISM AND HE VERIFIED ON X-RAY. SALES REP CONFIRMED NO PRODUCTS ARE BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLINE LARGE DIAMETER 14MM OVERSIZED SCREW APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY RAYNHAM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 186802040, SKYLINE TWO LEVEL PLATE