BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECOR MIDLINE CEMENT SAGING OSTEOTOME

    MDR report key: 4964035 · Received July 31, 2015

    Report

    Report Number
    3006396387-2015-00008
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED WITHIN OUR FACILITY FOR EVALUATION. UPON RECEIPT OF THE UNIT, A FINAL ANALYSIS WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT IS GOING TO BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION WAS CONDUCTED. THE CUSTOMER REPORTED EVENT OF THE DEVICE BEING BROKEN OR MISSHAPEN COULD NOT BE CONFIRMED AS NO KINK, BEND OR SLIGHT DEFORMATION WAS NOTED AT THE TIP OR ANY PART OF THE SHAFT OF THE DEVICE. THE TIP RETAINED ITS SHAPE AS FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE WAS EXAMINED UNDER A MICROSCOPE UNDER 0.7X MAGNIFICATION AND THE UNIT DID NOT REVEAL ANY INDICATION OF ANY PART BEING BROKEN OR MISSHAPEN AS WHAT THE INITIAL REPORT HAD INDICATED. THE ARTICULATION PORTION OF THE DEVICE APPEARED NORMAL AND PASSED ALL FUNCTIONAL TESTING CRITERIA. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. ALL UNITS ARE 100% VISUALLY INSPECTED AND TESTED FOR ITS FUNCTIONALITY DURING THE MANUFACTURING PROCESS. ONLY PASSING UNITS ARE MOVED TO THE NEXT PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE MIDLINE OSTEOTOME'S (MLO) INTEGRITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: THE MIDLINE OSTEOTOME (MLO) WAS USED ON 2 LEVELS, L2 AND L3. IT BROKE AND WAS UNABLE TO ARTICULATE DURING USE IN THE SECOND LEVEL. THE ARTICULATING PORTION BECAME MISSHAPEN. THE PHYSICIAN HAD DIFFICULTY REMOVING THE MLO AND NEARLY LOST ACCESS. THE PHYSICIAN CHOSE TO DELIVER THE CEMENT WITHOUT THE DESIRED AMOUNT OF CAVITIES. HE ULTIMATELY WENT BIPEDICULAR. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502021 VERTECOR MIDLINE CEMENT SAGING OSTEOTOME OSTEOTOME GFI DFINE INC. NA TLM-1408-26

    Patients

    Seq Age Sex Outcome Treatment
    1