BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HRS PLATE, FIXATION BONE

    MDR report key: 2991114 · Received March 6, 2013

    Report

    Report Number
    2520274-2013-01306
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PART IS AN UNKNOWN PLATE. BRAND NAME AND CATALOG NUMBER UNKNOWN. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AN IMPLANTED CONSTRUCT THAT WAS IMPLANTED (B)(6) 2012 FAILED 6 WEEKS AFTER IMPLANTATION. TWO OF THE THREE SCREWS IMPLANTED NEAR THE ARTICULAR SURFACE BROKE UNDER THE SCREW HEAD. NO FURTHER INFORMATION AVAILABLE. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95047 HRS PLATE, FIXATION BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention