BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECOR MIDLINE CEMENT STAGING OSTEOTOME

    MDR report key: 4993201 · Received July 31, 2015

    Report

    Report Number
    3006396387-2015-00010
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED WITHIN OUR FACILITY FOR EVALUATION. UPON RECEIPT, FINAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED EVENT OF THE MIDLINE OSTEOTOM (MLO) BEING DIFFICULT TO REMOVE AND CAME OUT COMPLETELY BENT COULD NOT BE CONFIRMED. HOWEVER, INVESTIGATION REVEALED THE TIP HAD A MINOR BEND WHICH IS SIMILAR TO DEVICES THAT ENCOUNTERED DENSE OR HARD BONE DURING USE. THE DEVICE'S DISTAL END IS FLEXIBLE, BENDING OUT OF STABILITY INTRODUCER DURING DEPLOYMENT. ALTHOUGH THE TIP SUSTAINED MINOR BEND, THE CONCENTRATION OF STRESS AT ITS BEND EXHIBITED ADEQUATE STRENGTH TO WITHSTAND INSERTION AND REMOVAL FROM CANCELLOUS BONE WHEN PLACED THROUGH AN INTRODUCER WITH NO BREAKAGE SUSTAINED UNDER FORCE. THE DEVICE WAS SAFELY WITHDRAWN. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. ALL UNITS ARE 100% INSPECTED AND TESTED FOR ITS FUNCTIONALITY DURING THE MANUFACTURING PROCESS AND ONLY PASSING UNITS ARE MOVED TO THE NEXT PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE MIDLINE OSTEOTOME'S 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: DURING PROCEDURE, THE MIDLINE OSTEOTOME (MLO) WAS INSERTED AND MADE 1 (ONE) PASS. THE BONE WAS REPORTED TO HAVE NOT BEEN DENSE OR SCLEROTIC. THE MIDLINE OSTEOTOME WAS DIFFICULT TO REMOVE AND CAME OUT COMPLETELY BENT. THE PHYSICIAN DID NOT ATTEMPT TO MAKE ANOTHER PASS. ONE CHANNEL WAS MADE FOR CAVITY CREATION AND THE CEMENT WAS EVENTUALLY DELIVERED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501616 VERTECOR MIDLINE CEMENT STAGING OSTEOTOME OSTEOTOME GFI DFINE INC. NA 150521

    Patients

    Seq Age Sex Outcome Treatment
    1