BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J & J CODMAN

    MDR report key: 468128 · Received June 23, 2003

    Report

    Report Number
    MW1028796
    Event Type
    Malfunction
    Date Received
    June 23, 2003
    Date of Event
    June 18, 2003
    Report Date
    June 23, 2003
    Manufacturer
    JARIT
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 12/9/03: RTPR MISTAKENLY REPORTED THE MFR AS J&J HEALTHCARE. RECENT INVESTIGATION REVEALS MFR TO BE JARIT.

    Description of Event or Problem · 1

    PERFORMING LUMBAR FUSION - SCREW CAME OUT OF INSTRUMENT - NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J CODMAN KERRISON KWQ JARIT WC 11 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR