INVISALIGN SYSTEM - MODERATE

Description of Event or Problem

THE TREATING DOCTOR REPORTED THAT THE PATIENT HAS BEEN DIAGNOSED WITH LEFT TEMPOROMANDIBULAR JOINT (TMJ) ANTERIOR DISC DISPLACEMENT WITHOUT REDUCTION, HAD SYMPTOMS OF JAW LOCKING ON THE LEFT SIDE, INABILITY TO OPEN THE MOUTH PROPERLY, AND PAIN UPON ATTEMPTING TO OPEN THE MOUTH, AS WELL AS SENSITIVITY WHILE EATING AND SPEAKING. THE PATIENT REPORTED VISITING A SPECIALIST AND REQUIRED MEDICAL INTERVENTION CONSISTING OF ARTHROCENTESIS, WITH REGENERATIVE MEDICINE PLANNED. THE PATIENT INDICATED TAKING A MUSCLE RELAXANT TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON 12/9/2025 AND THE PATIENT IS CURRENTLY EXPERIENCING MILD PERSISTENT SYMPTOMS, INCLUDING SENSITIVITY WHILE EATING AND SPEAKING

Additional Manufacturer Narrative

THE CURRENT INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: "PRECAUTIONS - IN RARE INSTANCES, PROBLEMS IN THE TEMPORO-MANDIBULAR JOINT (JAW JOINT) MAY RESULT IN JOINT PAIN, HEADACHES, OR EAR PROBLEMS.". POTENTIAL ROOT CAUSE NOT IDENTIFIED. WHEN ASKED HOW IS THE PATIENT DOING BY NOW TREATING DOCTOR SHARED THE FOLLOWING: SYMPTOMS PERSISTS SENSITIVITY WHILE EATING AND SPEAKING, IS CURRENTLY MILD. THERE IS NO CONCLUSIVE EVIDENCE PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. BASED ON THE AVAILABLE INFORMATION, THE PATIENT HAD REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, AND THE INVISALIGN SYSTEM WAS BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803.