BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEOJECT BONE CEMENT DELIVERY MINI KIT

    MDR report key: 935791 · Received October 30, 2007

    Report

    Report Number
    2023988-2007-00061
    Event Type
    Malfunction
    Date Received
    October 30, 2007
    Report Date
    October 30, 2007
    Manufacturer
    INTEGRA NEUROSCIENCES
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO SYRINGES (COMPONENT #1111208; LOT #3050000964164) BROKE WHERE THE COLLAR AND BARREL OF THE SYRINGE MEET. THE BREAKAGE OCCURRED DURING A PROCEDURE, WHILE THE PHYSICIAN WAS TRYING TO INJECT SOFT CEMENT INTO THE PATIENT. TRADEMARK PLASTICS INC., THE MANUFACTURER HAS BEEN MADE AWARE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOJECT BONE CEMENT DELIVERY MINI KIT * KIH INTEGRA NEUROSCIENCES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *