BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 42MM

    MDR report key: 7246061 · Received February 6, 2018

    Report

    Report Number
    8030965-2018-50907
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Report Date
    January 16, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819004672
    PMA / PMN Number
    K974537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE EVENT OCCURRED. ADDITIONAL PROCODES: KTT. THE DEVICE WAS NOT IMPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT DURING ATTACHMENT OF A PLATE TO THE FEMUR, TWO (2) CORTICAL SCREWS BROKE. BOTH SCREWS BROKE AT THE TRANSITION SCREW HEAD / SCREW SHAFT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR A SCREW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86792 4.5MM CORTEX SCREW SELF-TAPPING 42MM SCREW,FIXATION,BONE HWC OBERDORF : SYNTHES PRODUKTIONS GMBH 07611819004672

    Patients

    Seq Age Sex Outcome Treatment
    1