BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX LATERAL-SA SYSTEM

    MDR report key: 3950695 · Received June 6, 2014

    Report

    Report Number
    3004485144-2014-00007
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    OVD
    PMA / PMN Number
    K123767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO BACK A SCREW OUT SO THAT IT COULD BE RE-DIRECTED, THE DISTAL TIP OF THE SCREWDRIVER BROKE WITHIN THE SCREW HEAD. THE INSTRUMENT TIP WAS NOT RECOVERED AND REMAINS CAPTURED WITHIN THE SCREW HEAD BY THE MATING COVER PLATE COMPONENT. THERE WAS NO REPORT OF HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331790 LANX LATERAL-SA SYSTEM INTERVERTEBRAL BODY FUSION DEVICE/ OVD, MAX, MQP, ODP OVD BIOMET SPINE LLC 8630-0107 TU00659

    Patients

    Seq Age Sex Outcome Treatment
    1