BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOVE-KERRISON RONGEURS, IMPROVED HANDLE, 40 DEG

    MDR report key: 1064441 · Received June 9, 2008

    Report

    Report Number
    2430952-2008-00012
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 9, 2008
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOVE-KERRISON RONGEUR WAS BEING USED DURING A SPINAL FUSION PROCEDURE AND IT FELL APART. THERE WAS NO PT INJURY REPORTED. NO FURTHER INFO WAS AVAILABLE. VISUAL INSPECTION UPON RECEIPT FOUND THE TOP RAIL OF THE LOVE-KERRISON WAS NOT ASSEMBLED TO THE BODY OF THE INSTRUMENT. THE DEVICE WAS RECEIVED IN TWO PIECES. THE INSTRUMENT HAD NO MISSING PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOVE-KERRISON RONGEURS, IMPROVED HANDLE, 40 DEG JARIT NEURO/SPINAL SURGERY HTX TONTARRA MEDIZINTECHNIK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1