ISOLITE SYSTEM MOUTHPIECE
Received Oct 16, 2013 · Event occurred Aug 1, 2013
Report 2032574-2013-00001 · MDR key 3426510
Device
Generic name
Isolite Mouthpiece
Manufacturer
Innerlite, Inc., Dba Isolite SystemsModel number
CIL0800Catalog number
CIL0800
Product problems
- Device Operates Differently Than Expected
Patient
50 YR
- Pain
Narrative
Description of Event or Problem
TWO WEEKS AFTER NORMAL DENTAL PROCEDURE TO REPLACE A FILLING, PATIENT EXPERIENCED JAW PAIN AND THE INABILITY TO CLOSE HIS MOUTH (TEMPOROMANDIBULAR JOINT DISORDER, TMJ). HE REPORTED THIS TO THE DENTIST WHO PERFORMED THE DENTAL PROCEDURE AT THAT TIME. THE DENTIST DID NOT NOTIFY US (THE MFR). THE PATIENT NOTIFIED US ON (B)(4) 2013. DENTIST PERFORMED A STANDARD DENTAL PROCEDURE FOR A FILLING IN A TOOTH OF THE PATIENT. THE DOCTOR USED AN ISOLITE SYSTEM AND ISOLITE SYSTEM MOUTHPIECE USED FOR RETRACING THE TONGUE, KEEPING THE MOUTH OPEN WITH THE BITE BLOCK (INTEGRATED INTO THE DESIGN OF THE MOUTHPIECE, UTILIZING THE VACUUM AND ILLUMINATION FEATURES OF THE...
Additional Manufacturer Narrative
PATIENT COMPLAINED TO DENTIST OF PAIN IN JAW, 2 WEEKS AFTER DENTAL PROCEDURE (FILLING) USING THE ISOLITE MOUTHPIECE. DENTIST REFERRED PATIENT TO ORAL SURGEON WHO DIAGNOSED PATIENT WITH TMJ (TEMPOROMANDIBULAR JOINT) DISORDER. AT THE TIME, THE PATIENT FILE THE COMPLAINT WITH US (MFR) HE HAD ALMOST FULLY RECOVERED BUT STILL HAD SOME LIMITED MOBILITY OF HIS JAW.