BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIA PLATE

    MDR report key: 2880199 · Received December 19, 2012

    Report

    Report Number
    2520274-2012-04163
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    PATIENT IMPLANTED WITH DISTAL TIBIA PLATE, TUBULAR PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. PATIENT REPORTED PAIN AT THE IMPLANT SITE AND IN THE TIBIA TALUS JOINT. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. PATIENT FRACTURES WERE HEALED AT TIME OF EXPLANT. THIS IS 1 OF 24 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIA PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention PLATES, SCREWS, WASHERS