BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD Ø6 HARD L200 TI

    MDR report key: 2945296 · Received February 6, 2013

    Report

    Report Number
    8030965-2013-00338
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    PMA / PMN Number
    K992739
    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 NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD REVIEW REPORTS: MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN AUSTRIA AS FOLLOWS: THE PATIENT POST OPERATIVELY HAS A BROKEN USS ROD AT S1. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50637 ROD Ø6 HARD L200 TI ROD MNH SYNTHES GMBH 1973325

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention