BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX FUSION SYS

    MDR report key: 4345264 · Received December 5, 2014

    Report

    Report Number
    3004485144-2014-00018
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 19, 2014
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    MAX
    PMA / PMN Number
    K102738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DIFFICULTY WITH SCREW INSERTION RESULTED IN A 30-45 MINUTE SURGICAL DELAY. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786031 LANX FUSION SYS INTERVERTEBRAL BODY FUSION DEVICE, MQP, ODP MAX BIOMET SPINE LLC 8510-XXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 8509-0114 (HALF PLATE)| 8509-0214 (FULL PLATE)