BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02887

    MDR report key: 3132947 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02887
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTW
    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. DATE OF IMPLANT IS UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH A PLATE ON AN UNSPECIFIED DATE FOR A CALCANEUS FRACTURE. REPORTEDLY THE PLATE BROKE IN SITU. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234767 KTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention