BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø4.5 L30 SST

    MDR report key: 3070017 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-01780
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K974537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. AS THE SCREW WAS NOT RETURNED IN ITS ORIGINAL PACKAGE, WE ARE NOT ABLE TO COMPREHEND WHERE SUCH A DEFECT COULD OCCUR. NEVERTHELESS WE HAVE FORWARDED THIS SCREW TO OUR MANUFACTURING PLANT FOR INVESTIGATION HERE THE FEEDBACK: THE SCREW IS CLEARLY DEFORMED IN SUCH A WAY THAT POSSIBLY OVER TIGHTENING HAS LEAD TO THIS DEFORMATION. IF DURING USE, TRANSPORT OR EVEN DURING MANUFACTURING COULD NOT BE DETERMINED. NOTE THAT WE HAVE NOT HAD A SINGLE COMPLAINT OF SUCH NATURE WITH THIS ITEM SO FAR.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN TAIWAN AS FOLLOWS: REPORTEDLY THE THREADS OF THE 4.5MM CORTEX SCREW IS WRONG. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172425 CORTSCR Ø4.5 L30 SST KTT SYNTHES GMBH 2744835

    Patients

    Seq Age Sex Outcome Treatment
    1