BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX LATERAL-SA SYSTEM

    MDR report key: 3802446 · Received February 21, 2014

    Report

    Report Number
    3004485144-2014-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    LANX, INC.
    Product Code
    OVD
    PMA / PMN Number
    K123767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING FINAL TIGHTENING 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
    110009 LANX LATERAL-SA SYSTEM INTERVERTEBRAL BODY FUSION DEVICE - OVD, MAX, MQP, ODP OVD LANX, INC. 8630-0107 TU00090F

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR 8607-5540 SCREW| 8607 SCREW