BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX SPINAL IMPLANT SYSTEM

    MDR report key: 7940494 · Received October 5, 2018

    Report

    Report Number
    3005031160-2018-00029
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Report Date
    October 5, 2018
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    ODP
    UDI-DI
    M697X03400151
    PMA / PMN Number
    K171075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT TWO INSERTERS FAILED IN THE FIELD. THE MALFUNCTION WAS DISCOVERED PRIOR TO IMPLANTATION DURING A SURGERY. AN ALTERNATE INSTRUMENT WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS. THE BROKEN INSERTER WAS RETURNED FOR EVALUATION WHERE IT WAS CONFIRMED THAT THE DISTAL PORTION OF THE THREADED POST USED TO HOLD TRIALS AND IMPLANTS WAS BROKEN OFF. THE DAMAGE TO THE INSERTER COULD BE REPLICATED BY APPLYING LATERAL FORCE TO THE IMPLANT/TRIAL WHILE NOT FULLY ENGAGED WITH THE THREADED POST OF THE INSERTER. A DHR REVIEW WAS PERFORMED AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR LOT RELEASE. THIS LOT HAS BEEN AVAILABLE FOR DISTRIBUTION SINCE 10/30/2012.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT TWO INSERTERS FAILED IN THE FIELD. THE MALFUNCTION WAS DISCOVERED PRIOR TO IMPLANTATION DURING A SURGERY. AN ALTERNATE INSTRUMENT WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781936 CALIX SPINAL IMPLANT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE ODP X-SPINE SYSTEMS, INC. X034-0015 I6345-0000 M697X03400151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other