BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVA PX EXPANDABLE INTERBODY DEVICE

    MDR report key: 12839920 · Received November 18, 2021

    Report

    Report Number
    3004638600-2021-00010
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Report Date
    October 19, 2021
    Manufacturer
    SPINE WAVE, INC.
    Product Code
    MAX
    PMA / PMN Number
    K141980
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS THE DEVICE REMAINS IN THE PATIENT. SURGEON REPORTS PATIENT IS AN ACTIVE WORKER WHO PERFORMS HEAVY LIFTING WHICH MAY BE ASSOCIATED TO THE EVENT. THE DATE OF IMPLANT, DEVICE CATALOG NUMBER AND LOT NUMBER WERE NOT REPORTED.

    Description of Event or Problem · 0

    AT APPROXIMATELY THREE MONTHS POST-OPERATIVELY DURING ROUTINE POST-OPERATIVE EXAMINATION, THE SURGEON IDENTIFIED A FRACTURED IMPLANT ON RADIOGRAPH. IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC WITH EXPECTED BONY FUSION VISIBLE; NO SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738752 LEVA PX EXPANDABLE INTERBODY DEVICE INTERVERTEBRAL BODY FUSION DEVICE MAX SPINE WAVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown