BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX MIS

    MDR report key: 5008743 · Received August 17, 2015

    Report

    Report Number
    3008524126-2015-00023
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 17, 2015
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NKB
    UDI-DI
    18257200028313
    PMA / PMN Number
    122901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING A LUMBAR FIXATION SURGERY ON (B)(6) 2015, THE TIP BROKE OFF THE ROD HOLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543513 PHOENIX MIS PHOENIX ROD HOLDRE/INSERTER NKB ORTHOFIX INC. 20-0214 32589-NC07 18257200028313

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other