BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX PEDICSCR Ø7 PREASSMBL L35 TAN GRE

    MDR report key: 3171588 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02949
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    October 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    PMA / PMN Number
    K992739
    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). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE MICROSCOPIC INVESTIGATION SHOW MARKS ON AND ALSO INSIDE THE PEDICLE SCREW HEADS INDICATING THAT THE HEADS POPPED OFF DURING FORCIBLE OR INADEQUATE USE. THE CAUSE IS UNKNOWN. NO MANUFACTURING FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING AN OPERATION ON AN UNKNOWN DATE, IT WAS NOTED THAT THERE WAS SEPARATED SCREW AND DUAL CORE IN THE OP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272601 CLICKX PEDICSCR Ø7 PREASSMBL L35 TAN GRE MNH SYNTHES GMBH 3231971

    Patients

    Seq Age Sex Outcome Treatment
    1