BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERTECOR MIDLINE OSTEOTOME 3.0

    MDR report key: 2253186 · Received September 1, 2011

    Report

    Report Number
    3006396387-2011-00007
    Event Type
    Other
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 31, 2011
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALY RELATED TO THE COMPLAINT. PRIOR TO RELEASE OF THE LOT, MECHANICAL TESTS WERE PERFORMED AND TEST RESULTS FOR THE LOT MET ALL SPECIFICATIONS. IT IS UNKNOWN WHAT CAUSED DIFFICULTY IN REMOVING THE MIDLINE OSTEOTOME FROM THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT IT WAS DIFFICULT TO REMOVE A MIDLINE OSTEOTOME FROM A PATIENT. ALTHOUGH THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT, THE PROCEDURE DURATION WAS EXTENDED BY APPROXIMATELY 3 HOURS AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. A MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTECOR MIDLINE OSTEOTOME 3.0 OSTEOTOME GFI DFINE INC. 1620 TLM-1009-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention