SOMNOMED AVANT ORAL APPLIANCE
Received Apr 15, 2026 · Event occurred Feb 1, 2026
Report MW5186846 · MDR key 24887469
Device
Generic name
Device, Anti-snoring
Manufacturer
Somnomed, Inc.Product problems
- Break
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PATIENT HAS A SOMNOMED AVANT ORAL APPLIANCE AND THE BAND USED TO CONNECT THE UPPER ARCH AND LOWER ARCH OF THE APPLIANCE BROKE IN THE POSTERIOR. THERE WAS NO DIRECT PATIENT HARM FROM THE MALFUNCTION, HOWEVER, WITH THE BAND BROKEN THE DEVICE IS DEFECT AND WILL NOT WORK. THE PATIENT HAD THE FIRST BAND BREAK ON (B)(6) 2026 AND A REPLACEMENT BAND BREAK ON (B)(6) 2026 (BOTH BANDS THAT BROKE WERE SIZE L8). THE PATIENT IS CURRENTLY ON A THIRD REPLACEMENT BAND AND IT IS WORKING FINE SO FAR AND THE DEVICE IS FUNCTIONAL AGAIN BUT WANTED TO REPORT THE PREVIOUS TWO DEFECTIVE SIZE L8 BANDS. PT: 4582. DEVICE: 1069.