Byte V18115Recalls & reported problems
Dentsply International Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D001V181151), received between Nov 22, 2024 and Mar 6, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility3
Patient problems
- Pain2
- Deformity/ Disfigurement1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2026Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A HYPERBYTE VIBRATION DEVICE USED BY A PATIENT CAUSED THEIR JAW TO LOCK. THEY STOPPED USE OF THE DEVICE DUE TO THIS.
Patient problems: Deformity/ Disfigurement; Pain
MAUDE report 24535722 ↗InjuryMay 19, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A HYPERBYTE VIBRATION DEVICE AGGRAVATED THE PATIENT'S TMJ. THEY STOPPED USING THE DEVICE.
Patient problems: Pain
MAUDE report 22047107 ↗InjuryNov 22, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS ALLEGED THAT THE PATIENT HAD AN ALLERGIC REACTION- FACIAL SWELLING (ANGIOEDEMA) - TO THE USE OF THE HYPERBYTE VIBRATION DEVICE. THE MOTHER OF THE PATIENT REPORTED THEIR DAUGHTER HAD TO GO TO THE ER FOR FACIAL SWELLING WHICH IS ALLEGED TO BE TRIGGED BY THE DEVICE. THE PATIENT IS AN ALIGNER WEARER. FURTHER INFORMATION IS REQUESTED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT. SINCE THE FACIAL SWELLING (ANGIOEDEMA), COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 20758965 ↗
Other Orthodontic vibratory accessory devices
- HyperByte ASM-20018-05Propel Orthodontics LLC · Orthodontic Vibratory Accessory1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.