BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 12473377 · Received September 15, 2021

    Report

    Report Number
    1030489-2021-01164
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 18, 2021
    Report Date
    September 15, 2021
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    PMA/510K: THIS PRODUCT IS NOT APPROVED IN UNITED STATES. HOWEVER, SIMILAR PRODUCT- 6950315, UAN-00885074451237 AND 510 (K)- K052180 IS APPROVED IN 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371376 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG G6950315 H5597454

    Patients

    Seq Age Sex Outcome Treatment
    1