BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECOR MIDLINE OSTEOTOME

    MDR report key: 4599033 · Received March 5, 2015

    Report

    Report Number
    3006396387-2015-00003
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 13, 2015
    Manufacturer
    DFINE INC.
    Product Code
    GFI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: PN 2483, ASSEMBLY OF VERTECOR MIDLINE CEMENT STAGING OSTEOTOME-LONG, LZ-FORM, REVISION AB, LOT TLM-1406-18 ((B)(4)). NO ANOMALIES WERE RELATED TO THE CUSTOMER COMPLAINT UPON REVIEW OF THE DHR DOCUMENTATION. TESTS REVIEWED: (B)(4), REV AM - END ITEM AUDIT TESTING - MECHANICAL TESTING SPECIFICATIONS WERE ALL MET FOR THE LOT. BONE CEMENT TESTING - TESTING SPECIFICATIONS WERE ALL MET. RAW MATERIAL EVALUATION OF DEVICE: PNPS 3765 REVISION AE, FIRST FRACTURE KIT, BLISTER PACK, SHORT (VM) LINKED O MATERIAL SPECIFICATIONS: (B)(4) REVISION AA MIDLINE OSTEOTOME ASSEMBLY SHORT, (B)(4) REVISION AB; REQUIRES THE RAW MATERIAL (B)(4). MEDICAL GRADE 316 STAINLESS STEEL; SIMILAR TO PEDICLE SCREWS, ARE COMMONLY USED AS PERMANENT IMPLANTS IN FUSION SPINE SURGERY. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A BILATERAL APPROACH WAS PERFORMED. THE MIDLINE OSTEOTOME DURING THE PROCEDURE BECAME STUCK IN THE VERTEBRAE. THE ARTICULATING TIP BECAME "KINKED" ON IMPACTION WITH THE MALLET. UPON REALIZING THIS, THE SURGEON TRIED TO REMOVE THE MLO. THE MLO WAS NOT MOVING AT ALL AND EXTREME FORCE WAS APPLIED TO TRY AND REMOVE OF APPROXIMATELY 10 MINUTES. EVENTUALLY THE INTRODUCER AND THE MLO CAME OUT LEAVING THE ARTICULATING TIP REMAINING IN THE PATIENT. THE MIDLINE OSTEOTOME WAS BROKEN INSIDE THE VERTEBRAL BODY AND THE TIP GOT LOST BETWEEN THE VERTEBRAL BODY AND THE PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152700 VERTECOR MIDLINE OSTEOTOME OSTEOTOME GFI DFINE INC. NA TLM-1406-18

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR