BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2 LVL CSLP GOLD

    MDR report key: 2841240 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03300
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART OR LOT NUMBER OF DEVICE PROVIDED, THEREFORE NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. DEVICE NOT BEING RETURNED FOR EVALUATION, NO FURTHER EVALUATION CAN BE PERFORMED. THE 510K NUMBER NOT ABLE TO BE DETERMINED WITHOUT A PART NUMBER. DEVICE MANUFACTURE DATE NOT ABLE TO BE DETERMINED WITHOUT A LOT NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NOT PREVIOUSLY SELECTED. CORRECTED DATA - UPDATE PRODUCT NAME, UPDATE AWARENESS DATE.

    Description of Event or Problem · 1

    HARDWARE REMOVAL OF CSLP PLATE (C4-C6) IMPLANTED APPROXIMATELY 15 YEARS AGO (DATE UNKNOWN). THE SURGEON PLANNED IMPLANT REMOVAL OF CSLP PLATE AND IMPLANT VECTRA PLATE PRIOR TO TREATMENT DUE TO PATIENTS PROGRESSIVE DEGENERATIVE DISC DISEASE. THE CONSULTANT INFORMED THE SURGEON PRIOR TO IMPLANT REMOVAL THAT THE PATIENTS X-RAY REVEALED THAT THE CSLP IMPLANT WAS BROKEN. THE SURGEON PROCEEDED TO REMOVE THE CSLP IMPLANT AND SIX SCREWS (TYPE UNSPECIFIED) AS PLANNED AND IMPLANT THE NEW VECTRA PLATE (C6-C7) WITH SATISFACTORY RESULTS. THE CONSULTANT REPORTED THE REVISION WAS NOT DONE AS A RESULT OF THE BROKEN PLATE. PATIENT RETAINED THE EXPLANTED DEVICES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 LVL CSLP GOLD SCREW HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention PLATE, SCREWS