BEUDAMED
    FDA Adverse Event Other Summary report: N

    KERRISON RONGEUR

    MDR report key: 96591 · Received June 9, 1997

    Report

    Report Number
    1421584-1997-00001
    Event Type
    Other
    Date Received
    June 9, 1997
    Date of Event
    February 14, 1997
    Report Date
    June 9, 1997
    Manufacturer
    REDMOND NEUROTECHNOLOGIES CORP.
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON OCTOBER 24, 1997, PERSONNEL FROM REDMOND NEUROTECHNOLOGIES CORP VISITED THE HOSP. IT WAS DETERMINED BY THE VISIT, THE ACTUAL CATALOG NUMBER OF THE KERRISON RONGEUR. THE INSTRUMENT IS STILL BEING HELD, PENDING LAWSUIT. ON DECEMBER 1, 1997 HEYER-SCHULTE NEUROCARE, L.P. WAS INFORMED BY THE INITIAL DIST (IMPORTER OF RECORD) OF THE PRODUCT THAT THIS CATALOG NUMBER WAS A PRE-ADMENDMENT DEVICE, THEREFORE CO IS SUBMITTING A BASELINE REPORT AS OF THIS DATE. THERE WAS NO INFO AVAILABLE TO DETERMINE THIS PRIOR TO 12/01/1997.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR LAMINECTOMY PROCEDURE,THE SCREW BACKED OUT OF A REDMOND KERRISON AND THE INSTRUMENT DISASSEMBLED IN THE SURGEON'S HAND. PLAINTIFF REPORTS OF INJURY BY THE PRODUCT DURING SURGERY. REDMOND NEUROTECHNOLOGIES CORPORATION BECOME AWARE OF LAWSUIT VIA LEGAL DOCUMENTATION FILED MARCH 19, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KERRISON RONGEUR KERRISON RONGEUR HAE REDMOND NEUROTECHNOLOGIES CORP. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other