BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX FUSION SYS

    MDR report key: 3938960 · Received June 6, 2014

    Report

    Report Number
    3004485144-2014-00008
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    MAX
    PMA / PMN Number
    K102738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE HEX SOCKET OF THE BONE SCREW STRIPPED DURING INSERTION. THE DAMAGED SCREW WAS SUCCESSFULLY REPLACED, BUT A 40 MINUTE SURGICAL DELAY ENSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333303 LANX FUSION SYS INTERVERTEBRAL BODY FUSION DEVICE, MQP, ODP MAX BIOMET SPINE LLC 8610-5025

    Patients

    Seq Age Sex Outcome Treatment
    1