BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX LATERAL - SA SYSTEM

    MDR report key: 4105593 · Received September 9, 2014

    Report

    Report Number
    3004485144-2014-00011
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    BIOMET SPINE, LLC
    Product Code
    OVD
    PMA / PMN Number
    K123767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF THE BONE SCREW, THE DRIVER HEX TIP BROKE OFF INTO THE SCREW HEAD AND WAS NOT RETRIEVABLE, THERE WERE NO REPORTS OF INTRAOPERATIVE OR POSTOPERATIVE ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556347 LANX LATERAL - SA SYSTEM INTERVERTEBRAL BODY FUSION DEVICE OVD BIOMET SPINE, LLC 8630-0107 TU00157B

    Patients

    Seq Age Sex Outcome Treatment
    1