BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOICE SPINE VEO

    MDR report key: 5735188 · Received June 20, 2016

    Report

    Report Number
    5735188
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 17, 2016
    Manufacturer
    CHOICE SPINE, LP
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SCREW OF AN INSERTER BROKE OFF WHILE IT WAS BEING UTILIZED DURING SURGERY. NO PIECES REMAINED IN THE OPERATIVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390985 CHOICE SPINE VEO INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX CHOICE SPINE, LP 21-0544 314231R

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR