BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ATRIXNEURO BURR HOLE COVER F/BURRHOLES-

    MDR report key: 3183655 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03913
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Date of Event
    March 7, 2012
    Report Date
    April 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE PRESENT MATRIXNEURO BURR HOLE COVER WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. ALSO WE ARE NOT AWARE OF ANY SIMILAR OCCURRENCE REGARDING THIS ARTICLE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. IT IS CLEARLY VISIBLE THAT THE RING WAS DEFORMED BEFORE IT BROKE. ALSO THERE ARE STRESS MARKS WITHIN THE HOLE THAT ARE VISIBLE. THIS LETS US ASSUME THAT DURING THE INSERTION AN EXCESSIVE CONTACT BETWEEN THE SCREW AND THE PLATE CAUSED THIS OCCURRENCE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HOLE WAS TORN FROM THE MAIN PART. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284210 1ATRIXNEURO BURR HOLE COVER F/BURRHOLES- GXR SYNTHES GMBH 7693428

    Patients

    Seq Age Sex Outcome Treatment
    1