BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2900307 · Received January 7, 2013

    Report

    Report Number
    2520274-2013-00122
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SUFFERED FROM A GUNSHOT WOUND TO PHALANX AND WAS IMPLANTED WITH A PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE. PATIENT REPORTED FEELING PAIN AT THE IMPLANT ON AN UNKNOWN DATE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED WITH COMPETITORS PLATE AND BONE GRAFT. THIS IS 1 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6222 PLATE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCREWS