BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 34MM

    MDR report key: 3150097 · Received April 17, 2013

    Report

    Report Number
    2520274-2013-02009
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    (B)(4) WAS RECEIVED AND A COPY OF THE USER FACILITY MEDWATCH REPORT WILL BE INCLUDED IN THIS REPORT. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165772 4.5MM CORTEX SCREW SELF-TAPPING 34MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1