BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCIPITAL-PL 4.5/5 MED W/50 TI

    MDR report key: 2960243 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-00446
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    July 19, 2012
    Report Date
    January 16, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    K091689
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE IN (B)(6) 2012, THE DOCTOR WAS USING THE OCCIPITAL PLATE AND THE PLATE WAS REPORTEDLY BROKEN BEFORE THE DOCTOR COULD FIX IT INTO THE PATIENT. THE PLATE WAS REPLACED WITH A NEW PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64872 OCCIPITAL-PL 4.5/5 MED W/50 TI PLATE KWP SYNTHES GMBH 7512796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention