BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOFIX FORZA-PTC / ORTHOFIX

    MDR report key: 6621514 · Received June 6, 2017

    Report

    Report Number
    MW5070246
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    November 15, 2016
    Report Date
    April 10, 2017
    Manufacturer
    ORTHOFIX
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    POOR OUTCOME REQUIRING REDO SURGERY AS THE CAGE BODY SLIPPED AND / OR MIGRATED AFTER PLACEMENT, CAUSING INCREASED PAIN AND RADICULAR SYSTEMS. SURGERY L3-L4 DISCECTOMY AND RIGHT MICRODISCECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397827 ORTHOFIX FORZA-PTC / ORTHOFIX ORTHOFIX FORZA-PTC MAX ORTHOFIX 38-1711SP 001
    397844 FIREBIRD SCREW ORTHOFIX FIREBIRD SCREW NKB ORTHOFIX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other