FDA Adverse Event Injury Summary report: N

GENIO IS

MDR report key: 25017760 · Received April 28, 2026

Report

Report Number
3030384402-2026-00001
Event Type
Injury
Date Received
April 28, 2026
Date of Event
March 29, 2026
Report Date
April 28, 2026
Manufacturer
NYXOAH INC
Product Code
MNQ
PMA / PMN Number
P240024
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE PATIENT UNDERWENT IMPLANTATION OF THE GENIO SYSTEM ON DATE (B)(6) 2026. APPROXIMATELY 48 HOURS POSTOPERATIVELY (SUNDAY, DATE (B)(6) 2026), THE PATIENT CONTACTED THE IMPLANTING SURGEON REPORTING NECK SWELLING. INITIAL CONSERVATIVE MANAGEMENT WAS RECOMMENDED. FOLLOWING REPORTS OF PROGRESSIVE SWELLING, THE PATIENT WAS ADVISED TO PRESENT TO THE EMERGENCY DEPARTMENT. THE IMPLANTING SURGEON EVALUATED THE PATIENT IN THE EMERGENCY DEPARTMENT AND ELECTED TO PROCEED TO THE OPERATING ROOM FOR HEMATOMA EVACUATION. DURING PREPARATION IN THE OPERATING ROOM, PROGRESSIVE AIRWAY COMPROMISE OCCURRED SECONDARY TO THE EXPANDING HEMATOMA. THE ANESTHESIA TEAM WAS UNABLE TO SECURE THE AIRWAY, AND THE SURGEON PERFORMED AN EMERGENT TRACHEOSTOMY TO ESTABLISH A DEFINITIVE AIRWAY. OXYGENATION WAS MAINTAINED, AND THERE WAS NO EVIDENCE OF PROLONGED HYPOXEMIA. THE SURGEON SUBSEQUENTLY EVACUATED THE HEMATOMA AND IDENTIFIED A BLEEDING SOURCE LOCATED SUPERFICIAL TO THE IMPLANT PLANE, JUST DEEP TO THE PLATYSMA, AND NOT INVOLVING THE ANATOMICAL COMPARTMENT OF THE DEVICE. HEMOSTASIS WAS ACHIEVED AND A SURGICAL DRAIN WAS PLACED. THE PATIENT WAS MONITORED POSTOPERATIVELY WITHOUT RECURRENCE OF HEMATOMA AND WAS DISCHARGED WITH THE TRACHEOSTOMY IN PLACE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
54703 GENIO IS GENIO IS MNQ NYXOAH INC

Patients

Seq Age Sex Outcome Treatment
1 NA Male Hospitalization| R| O