BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 10274799 · Received July 15, 2020

    Report

    Report Number
    1030489-2020-00909
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    July 15, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958830, 510K # K081297 WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS IN A FUSION SURGERY AT C7-T1. IT WAS REPORTED THAT THE T1 SCREW HAD LOOSENESS AND NECKPAIN OCCURRED. REPLACEMENT OF T1 WAS PERFORMED. SCREWS AT C7-T1 WERE REMOVED, AND FIXATION WAS PERFORMED AGAIN AT C5-6-7-T1-2. HEALTH DAMAGE IN THE PATIENT WAS REPORTED. IT WAS ALSO NOTED THAT THERE WAS NO PRODUCT MALFUNCTION. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739418 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G6957630 H5382889

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R