BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO IS

    MDR report key: 24226738 · Received January 30, 2026

    Report

    Report Number
    3017191859-2026-00001
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    January 2, 2026
    Report Date
    January 30, 2026
    Manufacturer
    NYXOAH S.A.
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NYXOAH IS AWAITING THE RETURN OF THE IMPLANTABLE STIMULATOR FOR INVESTIGATION PURPOSES.

    Additional Manufacturer Narrative · 0

    NYXOAH IS AWAITING THE RETURN OF THE IMPLANTABLE STIMULATOR FOR INVESTIGATION PURPOSES. SUPPLEMENTAL CHANGES: ADDITION TO B5 AND E1.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PLANNED REVISION SURGERY OCCURRED, HOWEVER, NO NEW IMPLANTABLE STIMULATOR (IS) WAS PLACED. DURING THE REVISION, THE SURGICAL TEAM ENCOUNTERED EXTENSIVE CALCIFICATION SURROUNDING THE EXISTING IMPLANTABLE STIMULATOR. BONE FORMATION EXTENDED FROM THE HYOID BONE TO THE DEVICE, COVERING ROUGHLY HALF OF THE UPPER SURFACE OF THE IMPLANTABLE STIMULATOR BODY AND ANTENNA, AS WELL AS THE ENTIRE LOWER SURFACE. THE CALCIFICATION CONTINUED BENEATH THE IMPLANTABLE STIMULATOR, REACHED THE PADDLES, AND FILLED THE SPACE BETWEEN THE PADDLE SHOULDERS, FULLY ENCASING THEM. GIVEN THE SEVERITY OF THIS FINDING, THE SURGEON ELECTED NOT TO IMPLANT A REPLACEMENT IMPLANTABLE STIMULATOR, EXPRESSING CONCERN THAT THE ISSUE COULD RECUR. THE EXPLANT PROCEDURE WAS TECHNICALLY DIFFICULT AND LASTED NEARLY THREE HOURS, REQUIRING SPECIALIZED BONE-CUTTING INSTRUMENTS. ONE PADDLE SHOULDER WAS CUT DURING REMOVAL. BECAUSE OF THE DENSE CALCIFICATION AND THE MECHANICAL FORCES REQUIRED, THE EXTENT OF POTENTIAL DAMAGE TO THE EXTRACTED IS AND ITS SILICONE COATING IS NOT YET KNOWN. POTENTIAL CONTRIBUTING FACTORS INCLUDE CHRONIC FRICTION FROM BONE CONTACT SINCE IMPLANTATION AND PROGRESSIVE BONE FORMATION. THE EXPLANTED IMPLANTABLE STIMULATOR WILL BE SENT TO ENGINEERING FOR FURTHER ANALYSIS. A LIQUID DRAINAGE SYSTEM WAS PLACED INTRA-OPERATIVELY TO MANAGE PATIENT FLUIDS, INCLUDING BLOOD. CALCIUM FRAGMENTS AND TISSUE COLLECTED DURING SURGERY WILL BE SENT TO THE CLINIC'S LABORATORY FOR EVALUATION. THE SURGICAL TEAM REPORTED BEING CONCERNED BY THE DEGREE OF BONE BUILD-UP, WHICH DIRECTLY INFLUENCED THE DECISION TO FOREGO RE-IMPLANTATION. SUPPORTING IMAGES, INCLUDING PHOTOGRAPHS OF THE EXPLANTED IMPLANTABLE STIMULATOR AND ASSOCIATED CALCIFICATION ARE BEING TAKEN INTO CONSIDERATION THROUGH THE INVESTIGATION. NO PRE-REVISION X-RAY IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A PLANNED REVISION SURGERY OCCURRED, HOWEVER, NO NEW IMPLANTABLE STIMULATOR (IS) WAS PLACED. DURING THE REVISION, THE SURGICAL TEAM ENCOUNTERED EXTENSIVE CALCIFICATION SURROUNDING THE EXISTING IMPLANTABLE STIMULATOR. BONE FORMATION EXTENDED FROM THE HYOID BONE TO THE DEVICE, COVERING ROUGHLY HALF OF THE UPPER SURFACE OF THE IMPLANTABLE STIMULATOR BODY AND ANTENNA, AS WELL AS THE ENTIRE LOWER SURFACE. THE CALCIFICATION CONTINUED BENEATH THE IMPLANTABLE STIMULATOR, REACHED THE PADDLES, AND FILLED THE SPACE BETWEEN THE PADDLE SHOULDERS, FULLY ENCASING THEM. GIVEN THE SEVERITY OF THIS FINDING, THE SURGEON ELECTED NOT TO IMPLANT A REPLACEMENT IMPLANTABLE STIMULATOR, EXPRESSING CONCERN THAT THE ISSUE COULD RECUR. THE EXPLANT PROCEDURE WAS TECHNICALLY DIFFICULT AND LASTED NEARLY THREE HOURS, REQUIRING SPECIALIZED BONE-CUTTING INSTRUMENTS. ONE PADDLE SHOULDER WAS CUT DURING REMOVAL. BECAUSE OF THE DENSE CALCIFICATION AND THE MECHANICAL FORCES REQUIRED, THE EXTENT OF POTENTIAL DAMAGE TO THE EXTRACTED IS AND ITS SILICONE COATING IS NOT YET KNOWN. POTENTIAL CONTRIBUTING FACTORS INCLUDE CHRONIC FRICTION FROM BONE CONTACT SINCE IMPLANTATION AND PROGRESSIVE BONE FORMATION. THE EXPLANTED IMPLANTABLE STIMULATOR WILL BE SENT TO ENGINEERING FOR FURTHER ANALYSIS. A LIQUID DRAINAGE SYSTEM WAS PLACED INTRA-OPERATIVELY TO MANAGE PATIENT FLUIDS, INCLUDING BLOOD. CALCIUM FRAGMENTS AND TISSUE COLLECTED DURING SURGERY WILL BE SENT TO THE CLINIC'S LABORATORY FOR EVALUATION. THE SURGICAL TEAM REPORTED BEING CONCERNED BY THE DEGREE OF BONE BUILD-UP, WHICH DIRECTLY INFLUENCED THE DECISION TO FOREGO RE-IMPLANTATION. SUPPORTING IMAGES, INCLUDING PHOTOGRAPHS OF THE EXPLANTED IMPLANTABLE STIMULATOR AND ASSOCIATED CALCIFICATION ARE BEING TAKEN INTO CONSIDERATION THROUGH THE INVESTIGATION. NO PRE-REVISION X-RAY IS AVAILABLE. IT IS IMPORTANT TO NOTE THE IMPLANTABLE DEVICE IN THIS COMPLAINT FILE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282757 GENIO IS GENIO IS MNQ NYXOAH S.A. GENIO SYSTEM 2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other