InjuryLRK
SOMNODENT FLEX
Received Jul 3, 2024 · Event occurred Dec 12, 2023
Report MW5157034 · MDR key 19683040
Device
Generic name
Device, Anti-snoring
Manufacturer
Somnomed Inc.Patient
51 YR · Unknown
- Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
DURING 2022 AND 2023, THE SOMNOMED SOMNODENT FLEX DENTAL APPLIANCE CAUSED MY BITE TO CHANGE, LEADING TO JAW, HEAD AND CERVICAL SPINE PAIN, AND TO BITING OF INTERIOR GUM AND LIP FLESH WHEN CHEWING. TWO LOWER PLATES HAD TO BE REPLACED OVER TIME, AS THE SMALL TRIANGULAR FINS BROKE OFF IN MY MOUTH AT NIGHT; SUCH LOOSE TRIANGULAR FINS COULD BE SWALLOWED AND CAUSE INJURY.