BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX SPINAL IMPLANT SYSTEM

    MDR report key: 8262753 · Received January 18, 2019

    Report

    Report Number
    3005031160-2019-00003
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Report Date
    January 18, 2019
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    ODP
    UDI-DI
    M697C00300281
    PMA / PMN Number
    K171075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT A RASP BROKE OFF THE HANDLE WHILE THE SURGEON WAS REMOVING THE RASP FROM THE PATIENT. THERE WAS A SLIGHT SURGICAL DELAY WHILE THE SURGEON SUCCESSFULLY REMOVED THE RASP FROM THE PATIENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS. THE RASP WAS RETURNED FOR COMPLAINT ASSESSMENT. THE INSTRUMENT HAD SIGNS OF REPEATED USE. THE DAMAGE WAS PRESENT AS DESCRIBED BY THE COMPLAINANT. A DHR REVIEW WAS PERFORMED AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A RASP BROKE OFF THE HANDLE WHILE THE SURGEON WAS REMOVING THE RASP FROM THE PATIENT. THE SURGEON SUCCESSFULLY REMOVED THE RASP AND THERE WERE NO KNOWN PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52768 CALIX SPINAL IMPLANT SYSTEM INTERVERTEBRAL BODY FUSION DEVICE ODP X-SPINE SYSTEMS, INC. C003-0028 SPE1893 M697C00300281

    Patients

    Seq Age Sex Outcome Treatment
    1 Other