BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7649831 · Received June 29, 2018

    Report

    Report Number
    1030489-2018-00930
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 29, 2018
    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 PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 7753500,510K # K082728 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH CERVICAL SPONDYLOSIS AND UNDERWENT POSTERIOR CERVICAL SPINAL FUSION. DURING THE SURGERY, THE HEX PART OF THE MAS CROSSLINK SET SCREW WAS BROKEN.THE MAS CROSSLINK LOCKING SCREW WAS FIXED PROVISIONALLY, AND WHEN THE DOCTOR ATTEMPTED TO PROVISIONALLY FIX THE OTHER SIDE IN THE SAME WAY, THE HEX PART OF THE REPORTED PRODUCT WAS BROKEN. THEREFORE, IT WAS INSTALLED ON THE CONTRALATERAL SIDE AT C4, BUT IT WAS BROKEN AS WELL NO FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492845 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1