BEUDAMED
    FDA Adverse Event Other Summary report: N

    LANX CERVICAL SA INTERVERTEBRAL BODY FUSION SY

    MDR report key: 3016934 · Received March 18, 2013

    Report

    Report Number
    3004485144-2013-00008
    Event Type
    Other
    Date Received
    March 18, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    LANX, INC.
    Product Code
    OVE
    PMA / PMN Number
    112388
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF SURGICAL TECHNIQUE GUIDE FOUND INSTRUCTIONS TO BE SUFFICIENT. REVIEW OF DHR DID NOT IDENTIFY ANY MANUFACTURING ISSUES THAT WOULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    AN INTRAOPERATIVE COMPONENT DISSOCIATION RESULTED IN A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES. THE SURGEON ELECTED TO SWITCH SYSTEMS TO COMPLETE THE SURGERY. INCORRECT SURGICAL TECHNIQUE WAS REPORTED TO HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111942 LANX CERVICAL SA INTERVERTEBRAL BODY FUSION SY INTERVERTEBRAL BODY FUSION DEVICE OVE LANX, INC. 8409-0008

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCREW (8406-3512)| PEEK SPACER (8411-0508)| SCREW (8406-3514)