BEUDAMED
    FDA Adverse Event Summary report: N

    RHOTON

    MDR report key: 4218676 · Received October 27, 2014

    Report

    Report Number
    3007208013-2014-00017
    Date Received
    October 27, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SYMMETRY SURGICAL
    Product Code
    GZT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A SURGERY OF THE CERVICAL SPINE CALLED "FRYKROLM" SHE TICK THE LONGITUDINAL BAND TO TOUCH OR MOBILIZE AN INTERVERTEBRAL DISK SEQUESTER. A SMALL PIECE 2MM OF THE TIP GOT STUCK IN THE BAND. THE FACILITY IN (B)(6) REPORTED TO (B)(6): DURING A SURGERY OF THE CERVICAL SPINE CALLED "FRYKROLM" SHE TICK THE LONGITUDINAL BAND TO TOUCH OR MOBILIZE A INTERVERTEBRAL DISK SEQUESTER. A SMALL PIECE 2MM OF THE TIP GOT STUCK IN THE BAND. REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY RELEVANT TO THE CARE OF THE PATIENT: PROF. (B)(6) INFORMED THE PATIENT THAT FROM HER MEDICAL POINT OF VIEW THERE IS NO RISK AND SHE DIDN'T EXPECT ANY COMPLICATIONS. DEVICE TIP BROKE DURING SURGERY, DEVICE WAS NOT RETURNED TO SYMMETRY SURGICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684266 RHOTON NERVE HOOK GZT SYMMETRY SURGICAL 80-1689

    Patients

    Seq Age Sex Outcome Treatment
    1