BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECOR MIDLINE OSTEOTOME 3.0

    MDR report key: 2197322 · Received July 7, 2011

    Report

    Report Number
    3006396387-2011-00005
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 7, 2011
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER LOT OF VERTECOR MIDLINE OSTEOTOME 3.0 MAY BE: LOT#: TLM-1011-08, DOM: 11/12/2010, EXP DATE: 11/30/2011. THE VERTECOR MLO GOT STUCK IN THE THREADS OF A PRE-EXISTING PEDICLE SCREW AND BROKE WITHIN THE VERTEBRAL BODY. THE PHYSICIANS FELT IT IS BEST TO LEAVE THE TIP EMBEDDED IN CEMENT AND THAT IT WOULD CAUSE NO PROBLEMS TO THE PT. (B)(4). 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 SPECS. NO DEFINITIVE CONCLUSION CAN BE MADE AS THE IMPLANTED PORTION OF THE DEVICE IS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE MIDLINE OSTEOTOME GOT STUCK ON THE THREADS OF A PREVIOUSLY PLACED PEDICLE SCREW. THE ARTICULATING TIP BROKE OFF AND WAS RETAINED IN THE VERTEBRA OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTECOR MIDLINE OSTEOTOME 3.0 OSTEOTOME GFI DFINE INC. 1620 TLM-1011-02

    Patients

    Seq Age Sex Outcome Treatment
    1