BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE

    MDR report key: 2893778 · Received January 2, 2013

    Report

    Report Number
    2520274-2013-00034
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL NARRATIVE: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. 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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN ITALY AS FOLLOWS: VETERINARY PLATE WAS IMPLANTED IN (B)(6) MALE DOG (UNKNOWN DATE). IT WAS REPORTED THE PLATE BROKE IN SITU.

    Description of Event or Problem · 1

    THE DOG WAS INITIALLY TREATED WITH AN UNKNOWN EXTERNAL FIXATOR. AN INFLAMMATION OF THE BONE OCCURRED AND AN IMPLANTATION OF THE LCP PLATE WAS SCHEDULED. REPORTEDLY THE LCP PLATE BROKE AFTER 1.5 MONTHS POST-OPERATIVELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention