HYPERBYTE VIBRATION DEVICE

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

Description of Event or Problem

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.