BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAMPART-O 30X8

    MDR report key: 6180549 · Received December 15, 2016

    Report

    Report Number
    MW5066713
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 14, 2016
    Manufacturer
    SPINEOLOGY INC.
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING L4-S1 DECOMPRESSION/L5-S1 TLIF WITH SCREWS SURGERY, SPINEOLOGY CAGE RAMPART-O 30XB LOT #S15545 BROKE CAUSING NO APPARENT ANATOMICAL DAMAGE. PIECES OF THE CAGE WERE REMOVED IN THEIR ENTIRETY AND SAME SIZE CAGE RE-IMPLANTED. THE NEW CAGE IS LOT # S16024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830425 RAMPART-O 30X8 CAGE RAMPART MAX SPINEOLOGY INC. 30X8 S15545

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR