BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 9452021 · Received December 11, 2019

    Report

    Report Number
    1030489-2019-01413
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 11, 2019
    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 UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7755124, 510K # K082728 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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 HAD UNDERWENT POSTERIOR CERVICAL SPINAL FIXATION AT O-C2 DUE TO RETRO-ODONTOID PSEUDOTUMOR. ON (B)(6) 2019, POST-OP, WHEN THE PATIENT VISITED THE HOSPITAL, A SOUND WAS HEARD WHEN THE PATIENT BENT THE NECK. IMAGES WERE TAKEN AND BREAKAGE WAS FOUND AT THE CONNECTION PART OF THE ADJUSTABLE ROD. IT IS UNKNOWN WHETHER THE BREAKAGE WAS ON ONE SIDE OR BOTH SIDES. REPORTEDLY, THERE WAS NO IMPROVEMENT IN RETRO-ODONTOID PSEUDOTUMOR. THERE IS NO PLAN FOR RE-OPERATION AS NO NEW SYMPTOMS OCCURRED DUE TO THE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246595 VERTEX RECONSTRUCTION SYSTEM KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1