BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOMARK OR ECHOMARK LP

    MDR report key: 22587102 · Received July 24, 2025

    Report

    Report Number
    3014680735-2025-00001
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    February 26, 2020
    Report Date
    June 5, 2025
    Manufacturer
    SONAVEX, INC.
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THIS IS REPORTED AS A CLINICAL FINDING, THERE WAS NO EVIDENCE LINKING TO PRODUCT MALFUNCTION, AND NO OTHER FOLLOW UP PROCEDURE WAS PERFORMED. THE EVENT WAS DRIVEN BY THE IMPLANT LOCATION. AS THE PHYSICIAN STATED, THE DEVICE SHOULD HAVE NOT BEEN PLACED UNDER IRRADIATED TISSUE.

    Description of Event or Problem · 0

    A POST-MARKET OBSERVATIONAL STUDY WAS CONDUCTED ON THE ECHOMARK AND ECHOSURE, PROTOCOL NUMBER 2019-1,"OBSERVATIONAL STUDY OF OUTCOMES AFTER ECHOMARK AND ECHOSURE-BASED FREE FLAP MONITORING." FEEDBACK WAS RECEIVED FROM A PHYSICIAN IN THE OBSERVATIONAL CLINICAL STUDY, WHO REPORTED A POTENTIAL ECHOMARK EXTRUSION IN A PATIENT WHO UNDERWENT A HEAD AND NECK RECONSTRUCTION SURGERY. FURTHER INFORMATION PROVIDED TO SONAVEX STATED THAT THE PATIENT HAD COMPLAINED ABOUT SWELLING NEAR THE INCISION AND JAW LINE. WHEN THE PHYSICIAN PALPATED THE PATIENT, HE DID NOT FEEL THE ECHOMARK AND STATED IT JUST FELT LIKE FOCAL AREA SWELLING. THE PATIENT HAD A CT SCAN TO MAKE SURE THERE WAS NO ISSUE WITH THE BONE OR AN INFECTION. AFTER FURTHER REVIEW THE PHYSICIAN REPORTED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE CHEMOTHERAPY AND RADIATION. THE PHYSICIAN STATED THAT HE BELIEVED THE ISSUE RESULTED FROM THE ECHOMARK BEING PLACED UNDER PREVIOUSLY IRRADIATED TISSUE AND ULTIMATELY WAS VISIBLE DUE TO POOR WOUND HEALING FROM THE RADIATION. HE NOTED SIMILAR EXPERIENCES WITH OTHER DEVICES IN RADIATED PATIENTS AND DID NOT HAVE ANY CONCERN WITH THE ECHOMARK ITSELF. THE PHYSICIAN DETERMINED THIS EVENT WAS NOT REPORTABLE TO IRB UNDER THE OBSERVATIONAL STUDY AND TOOK NO FURTHER ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187224 ECHOMARK OR ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER NEU SONAVEX, INC. 3000/2000 P-14517/P-14518/P-14526

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other