BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIUS VITALLIUM ROD 5.5 X 600 MM

    MDR report key: 2885114 · Received December 19, 2012

    Report

    Report Number
    9617544-2012-00584
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K082608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "REVISION SURGERY FOR A BROKEN 5.5 RADIUS VITALLIUM ROD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIUS VITALLIUM ROD 5.5 X 600 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA UCA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R