BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 6629021 · Received June 9, 2017

    Report

    Report Number
    1030489-2017-01484
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 16, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 7753500, 510K# K082728 AND (B)(4) IS APPROVED FOR THE MARKET IN THE US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IMAGE REVIEW: SUBMITTED IMAGES APPEAR TO DISPLAY BROKEN CONNECTOR SCREWS.

    Description of Event or Problem · 1

    PROCEDURE: CERVICAL POSTERIOR FUSION IT WAS REPORTED THAT DURING SURGERY, THE TOP CONNECTION PART OF CROSSLINK SET SCREW BROKE DURING FINAL TIGHTENING. THE IMPLANT WAS PARTIALLY REMOVED, HOWEVER NO FRAGMENTS OF THE IMPLANT REMAINED INSIDE THE PATIENT POST SURGERY. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412476 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0467684W

    Patients

    Seq Age Sex Outcome Treatment
    1