BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECOR MIDLINE CEMENT STAGING OSTEOTOME

    MDR report key: 5057599 · Received August 31, 2015

    Report

    Report Number
    3006396387-2015-00012
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIDLINE OSTEOTOME ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THREE FOLLOW-UP ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE BUT WERE UNSUCCESSFUL. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE MALFUNCTION REPORTED COULD NOT BE DETERMINED. SHOULD THIS PRODUCT RETURN AT A LATER DATE, THIS COMPLAINT WILL BE RE-OPENED AND A FINAL ANALYSIS WILL BE CONDUCTED ACCORDINGLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT/SERIAL (B)(4) PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RECEIVED WITHIN OUR FACILITY AT THIS TIME. AS SOON AS THE DEVICE IS RECEIVED, AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE DISTRIBUTOR INDICATED THAT THE MIDLINE OSTEOTOME (MLO) WAS IN THE SHIRT WHEN A CHANNEL WAS BEING CREATED FOR CEMENT INFUSION (THE BONE WAS DESCRIBED TO BE A LITTLE HARDER THAN USUAL) WHEN IT GOT STUCK. AS THE PHYSICIAN TRIED TO REMOVE IT, THE MLO BROKE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED TO RETRIEVE THE BROKEN PIECE OF THE OSTEOTOME INSIDE THE PT'S BODY. THE PHYSICIAN DECIDED TO WORK ON THE VERTEBRAL BODY WITH ANOTHER PEDICLE AND COMPLETED THE PROCEDURE WITH NO REPORT OF PT INJURY. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575938 VERTECOR MIDLINE CEMENT STAGING OSTEOTOME OSTEOTOME GFI DFINE INC. NA M209619

    Patients

    Seq Age Sex Outcome Treatment
    1