BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 14MM

    MDR report key: 2842711 · Received November 21, 2012

    Report

    Report Number
    1719045-2012-01189
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE USED FOR TREATMENT.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. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    CONSULTANT REPORTS TWO PROCEDURES PERFORMED ON ONE SURGERY. PATIENT IMPLANTED ON UNKNOWN DATE WITH TWO SCREWS AND TWO WASHERS ON TIBIA PLATEAU. PATIENT ALSO IMPLANTED WITH LCP ONE THIRD TUBULAR PLATE, SIX SCREWS, AND ONE MALLEOLAR SCREW. IT IS UNKNOWN WHICH CONSTRUCT WAS IMPLANTED FIRST. PATIENT COMPLAINED OF IRRITATION AND REQUESTED REMOVAL OF ALL HARDWARE. PATIENT WAS RETURNED TO OR ON (B)(6) 2012. FIRST PROCEDURE WAS REMOVAL OF THE SCREWS FROM THE TIBIA PLATEAU. HARDWARE APPEARED INTACT, FRACTURE APPEARED HEALED. SURGEON THEN REMOVED THE LCP ONE THIRD TUBULAR PLATE AND ALL SCREWS. THIS CONSTRUCT ALSO APPEARED INTACT AND FRACTURE APPEARED HEALED. THIS IS 10 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM CORTEX SCREW SELF-TAPPING 14MM CORTEX SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention SCREW, WASHER, PLATE