BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 5369108 · Received January 15, 2016

    Report

    Report Number
    1030489-2016-00156
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Date of Event
    December 1, 2015
    Report Date
    December 16, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). UNKNOWN PMA 510(K): THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PART WITH CATALOGUE NUMBER 7753919 WITH 510K NUMBER K123906 IS APPROVED FOR SALE IN THE US. NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES AVAILABLE. HENCE, IT IS DIFFICULT TO DRAW ANY CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE 16MM CLOSED CONNECTOR TO A 19MM CLOSED CONNECTOR AND TO ADD CROSS LINK. IN MIDDLE OF (B)(6), AN X-RAY WAS CARRIED OUT AND IT WAS FOUND THAT THE ROD WAS DISLOCATED. REPORTEDLY, THE PATIENT WAS NOT SCHEDULED FOR REVISION SURGERY BECAUSE THERE WAS NO SUBJECTIVE SYMPTOM IN THE PATIENT. SET SCREW OF THE CONNECTOR WAS LOOSE WHICH COULD BE THE PROBABLE CAUSE OF THE MOVEMENT OF THE ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29311 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1