HYPERBYTE VIBRATION DEVICE
Received May 19, 2025
Report 2424472-2025-00222 · MDR key 22047107
Device
Generic name
Orthodontic Vibratory Accessory
Manufacturer
Dentsply LlcCatalog number
V18115
Lot number
N/A
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
NA · Unknown
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.
Description of Event or Problem
IN THIS EVENT IT IS REPORTED THAT A HYPERBYTE VIBRATION DEVICE AGGRAVATED THE PATIENT'S TMJ. THEY STOPPED USING THE DEVICE.
Additional Manufacturer Narrative
NO PRODUCT WILL BE RETURNED FOR THIS COMPLAINT AND NO DHR REVIEW COMPLETED BECAUSE PRODUCT LOT NUMBER IS UNKNOWN.