BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX® RECONSTRUCTION SYSTEM

    MDR report key: 3171725 · Received June 16, 2013

    Report

    Report Number
    1030489-2013-02326
    Event Type
    Malfunction
    Date Received
    June 16, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K042524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING FINAL TIGHTENING IT WAS REPORTED THAT THE CENTER NUT OF THE CROSSLINK SHEARED OFF. THE BROKEN PIECES WERE REMOVED AND A NEW IMPLANT WAS INSERTED WITHOUT INCIDENT. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272725 VERTEX® RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1