BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2872282 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03884
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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 A PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. ON AN UNKNOWN DATE, PATIENT COMPLAINED OF PAIN FROM A HEALED FRACTURE. THE SURGEON DECIDED TO REMOVE HARDWARE TO ALLEVIATE THE PAIN. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND THE HARDWARE WAS REMOVED. THIS IS 9 OF 9 REPORTS FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention SCREW X 8