BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 38MM

    MDR report key: 2871646 · Received December 13, 2012

    Report

    Report Number
    1719045-2012-01338
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 4.5 MM LCP PROXIMAL TIBIA PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. PATIENT COMPLAINED OF PAINFUL HARDWARE FROM THE LEFT PROXIMAL TIBIA. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS. THIS REPORT IS #10 OF 11 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM CORTEX SCREW SELF-TAPPING 38MM 4.5MM CORTEX SCREW SELF-TAPPING 38MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PLATE, SCREWS