MAUDE Adverse Event Report: DENTSPLY LLC HYPERBYTE VIBRATION DEVICE; ORTHODONTIC VIBRATORY ACCESSORY

Catalog Number	V18115
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.Customer complaints are reviewed during monthly psc meetings.The failure mode mentioned in this complaint is also identified as a potential hazard in the corresponding risk management file.The device will not be returned for evaluation.Evaluation of device is not warranted for individual adverse effect or sensitivity to device usage.The lot number information required for a device history record (dhr) review was not provided.The user was instructed to immediately discontinue use of the product.Failure mode - tmj/lockjaw root cause - patients condition conclusion code - event caused by patient conditions/factors.
Event or Problem Description
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.

• Brand Name: HYPERBYTE VIBRATION DEVICE
• Common Device Name: ORTHODONTIC VIBRATORY ACCESSORY
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24535722
• Report Number: 2424472-2026-00596
• Device Sequence Number: 16050718
• Product Code: OYH
• UDI-Device Identifier: D001V181151
• UDI-Public: D001V181151
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: V18115
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female