BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 11122105 · Received January 6, 2021

    Report

    Report Number
    1030489-2021-00012
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 6, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIKE DEVICE WITH PART# 6950315, 510K# K052180, K052734 AND UPN (B)(4) IS APPROVED FOR MARKET IN THE US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE FOR AN EVENT DURING C3 \ C4 CERVICAL POS TERIOR DECOMPRESSION AND FIXATION PROCEDURES ON A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY. IT WAS REPORTED THAT THE SCREW STRIPPED AT THE TIME OF THE FINAL TIGHTENING. RE-TIGHTENING WAS PERFORMED THREE TIMES, BUT IT COULD NOT BE TIGHTENED, SO THE SET SCREW WAS REMOVED AND A NEW ONE WAS OPENED AND USED. THE NEW ONE WAS ABLE TO BE TIGHTENED WITH THE SAME DRIVER. THE TIP OF THE DRIVER SEEMED TO BE A LITTLE COLLAPSED. THE REMOVED SET SCREW WAS DISCARDED. THE DRIVER WILL BE RETURNED, AND BOTH PRODUCTS WERE REPLACED WITH MEDTRONIC PRODUCTS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22135 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G6950315 H5590628

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR