BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2903747 · Received January 9, 2013

    Report

    Report Number
    2520274-2013-00205
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 13, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 WAS IMPLANTED WITH PLATE AND SCREW FIXATION AT THE TALUS ON (B)(6) 2012. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 FOR THE REMOVAL OF THE HARDWARE DUE TO NON-UNION. NO HARDWARE WAS REPORTEDLY BROKEN. PATIENT WAS REVISED TO FOOT FUSION NAIL. THIS IS 2 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11205 PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention SCREWS, WASHER