BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVIOS WEDGE-SHAPED SIZ 7 PEEK

    MDR report key: 3192919 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-02760
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 19, 2011
    Report Date
    February 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE MEASURABLE DIMENSIONS OF THE BROKEN CERVIOS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL ANALYSES, STRENGTH AND STRUCTURAL STABILITY WERE FOUND WITHIN SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE DURING USE OR UNFORESEEN COMPLICATION MAY HAVE CAUSED THE BREAKAGE. THE BROKEN SURFACE IS HOMOGENOUS, WHAT INDICATES MATERIAL CONFORMITY AS WELL.

    Description of Event or Problem · 1

    BREAKAGE DURING INSERTION. THIS IS 1 OF 1 REPORT FOR EVENT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293604 CERVIOS WEDGE-SHAPED SIZ 7 PEEK JDQ SYNTHES GMBH 2605075

    Patients

    Seq Age Sex Outcome Treatment
    1