InjuryDYN
ISOLITE MOUTHPIECE
Received Nov 3, 2015 · Event occurred Sep 30, 2015
Report 2032574-2015-00004 · MDR key 5199238
Device
Product problems
- Mechanics Altered
Patient
34 YR
- Joint Dislocation
Narrative
Additional Manufacturer Narrative
COMPLAINT RECEIVED VIA PHONE FROM DENTIST. DEVICE DISPOSED OF BY DENTIST. DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem
DENTIST WAS PERFORMING 2 HOUR CROWN PREPARATION USING THE ISOLITE MOUTHPIECE (SIZE: SMALL). PATIENT JAW LOCKED OPEN DURING THE PROCEDURE. PATIENT HAS A HISTORY OF TMJ (TEMPORAL MANDIBULAR JOINT DISORDER). PHYSICIAN DIAGNOSIS WAS JAW DISARTICULATION (POST PROCEDURE) WHICH REQUIRE SURGERY THE NEXT DAY.