BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLIVIOS SIZ 7 PEEK

    MDR report key: 3141408 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02616
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    February 23, 2011
    Report Date
    March 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    PMA / PMN Number
    K011037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS AND EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. NO PRODUCT FAULT COULD BE DETECTED. THE CROSS SECTION SURFACE SHOWS NO IRREGULARITIES WHICH INDICATE MATERIAL CONFORMITY. HIGH MECHANICAL FORCE CAUSED THE DAMAGE TO THE CAGE- NO PRODUCT FAULT COULD BE DETECTED. THE INVESTIGATION DETERMINED THIS COMPLAINT TO BE INVALID.

    Description of Event or Problem · 1

    CAGE HIT HARD SCLEROTIC BONE AND FRACTURED ON IMPACTION. WHILE TRYING TO REMOVE THE PLIVIOS VERTEBRAL SPACER IMPLANT, IT BROKE INTO 2 PIECES. THE BROKEN PIECES WERE RETRIEVED. THE DOCTOR BELIEVED THAT THE FORCE OF IMPACTION FRACTURED THE DEVICE. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244625 PLIVIOS SIZ 7 PEEK MQP SYNTHES GMBH 2678184

    Patients

    Seq Age Sex Outcome Treatment
    1