BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR PLUSDRIVE Ø2 SELF-DRILL L4 TAN

    MDR report key: 3171606 · Received June 15, 2013

    Report

    Report Number
    1719045-2013-01560
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    September 8, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 A DEVICE MARKETED IN THE USA. THE DEVICE HISTORY DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES WERE DETECTED. NO MANUFACTURING RELATED FAULT COULD DO DETECTED. THE INVESTIGATION OF THE COMPLAINED CORTEX SCREW FOUND THAT THE DIAMETER IS 1.5MM, BUT THE LABEL ON THE OPENED PACKAGE SHOWS A SCREW WITH DIAMETER 2.0MM. THIS IS THE FIRST COMPLAINT RELATED TO THE ARTICLE AND LOT NUMBER IN QUESTION. THE CAUSE IS UNKNOWN. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, IT WAS NOTED THAT THE SIZE OF THE CORTEX SCREW WAS NOT WHAT WAS EXPECTED. IT IS UNKNOWN WHEN THIS OCCURRED. NO ADDITIONAL INFORMATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272500 CORTSCR PLUSDRIVE Ø2 SELF-DRILL L4 TAN HWC SYNTHES MONUMENT 6302516

    Patients

    Seq Age Sex Outcome Treatment
    1