BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 PRE-BENT ROD 5.5X40MM

    MDR report key: 1060515 · Received June 11, 2008

    Report

    Report Number
    3005673311-2008-00019
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 31, 2008
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL BE RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    REVISION L5 - S1. PSEUDOARTHROSIS. FUSION NOT ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4 PRE-BENT ROD 5.5X40MM KWP AESCULAP AG & CO. KG SW655T 51341048

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other