BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING

    MDR report key: 1170280 · Received September 18, 2008

    Report

    Report Number
    1719045-2008-00122
    Event Type
    Injury
    Date Received
    September 18, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PREAMEND
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO OBTAINED FROM OPERATIVE NOTES REC'D. NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. SYNTHES IS UNABLE TO DETERMINE THE MFR DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    OPERATIVE NOTES INDICATE SYMPTOMATIC HARDWARE, PT HAD HEALED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM CORTEX SCREW SELF-TAPPING CORTEX SCREW HWC SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATES