BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN:C2 SPINAL FIXATION SYSTEM

    MDR report key: 3972890 · Received June 27, 2014

    Report

    Report Number
    3006404071-2014-00003
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SPINE SMITH PARTNERS L.P.
    Product Code
    OVE
    PMA / PMN Number
    122630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANCIES WERE IDENTIFIED WITH THE DEVICE RECORDS, THE DEVICE SPECIFICATION AND THERE WERE NO DEFICIENCIES IDENTIFIED IN THE LABELING OR INSTRUCTIONS FOR USE. VISUAL EVAL AND EVAL USING A MICROSCOPE OF THE RETURNED COMPONENTS INDICATES THAT THE BONE SCREWS WERE IN CONTACT WITH THE PLATE AS THEY WERE BEING TURNED DAMAGING BOTH THE SCREWS AND THE PLATE. THIS COULD HAVE ALSO FORCED THE PLATE OFF THE PEEK COMPONENT. IT IS NOT KNOWN WHY THE SCREWS WERE IN CONTACT WITH THE PLATE, IF THE PROVIDED INSTRUMENTATION WAS IN USE, OR IF THERE ANY ANATOMICAL ISSUES THAT COULD HAVE CONTRIBUTED. THE DAMAGED SET SCREW APPEARS TO HAVE BEEN SHEARED OFF LIKELY FROM THE PLATE HOLDER AS BEING MANIPULATED. NO OTHER DISCREPANCIES WERE IDENTIFIED. NOTE: THE INFO CONTAINED THIS VOLUNTARY REPORT REPRESENTS THE MOST COMPLETE AND TO DATE INFO AVAILABLE. IT DOES NOT CONSTITUTE AND ADMISSIONS, BUT PRESENTS THE RESULTS OF THE INVESTIGATION BASED ON THE INFO AVAILABLE. THIS IS THE FINAL REPORT. SHOULD ANY ADDITIONAL DETAILS BECOME AVAILABLE THAT IMPACTS OF CHANGES THE INFO CONTAINED THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE PLACING THE SECOND SCREW IN TO THE TOP PLATE, THE PLATE BECAME SEPARATED FROM THE PEEK COMPONENT. THE SURGEON REMOVED THE PLATE AND WHILE REMOVING THE PLATE DAMAGED THE LOCKING SET SCREW. A DIFFERENT PLATE THAN THE INTENDED PLATE WAS PLACED OVER THE PEEK CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376338 IN:C2 SPINAL FIXATION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE, PRODUCT CODE: OVE OVE SPINE SMITH PARTNERS L.P. 1100-0070 54AS-R

    Patients

    Seq Age Sex Outcome Treatment
    1