LIGHTFORCE ORTHODONTIC SYSTEM

Additional Manufacturer Narrative

THE LIGHTFORCE ORTHODONTIC SYSTEM INSTRUCTIONS FOR USE CONTAIN THE PRECAUTION "INSTRUCT NO TO CHEW OR BITE HARD SUBSTANCES SUCH AS HARD CANDY, ICE, OR CARROTS. CAREFUL AND THOROUGH PATIENT INSTRUCTION IS KEY TO AVOIDING APPLIANCE OR ENAMEL DAMAGE". AN INTERNAL LOT RECORD REVIEW WAS ALSO CONDUCTED, AND THE RESULTS INDICATE THIS LOT WAS PROCESSED WITHOUT INCIDENT. THE ROOT CAUSE INVESTIGATION CONCLUSION FOR THIS ADVERSE EVENT IS THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS FDA CODE 18. THIS IS THE FIRST ELECTRONIC MDR SUBMITTTED BY THE COMPNAY AND THE REPORT WAS DELAYED DUE TO THE ESG / WEB TRADER SIGNUP PROCESS.

Description of Event or Problem

LIGHTFORCE ORTHODONTICS WAS NOTIFIED THAT THE ORTHODONTIST REMOVED A SINGE MOLAR TUBE (LR6) BRACKET FROM THE LIGTHFORCE ORTHODONTIC SYSTEM AND A PIECE OF ENAMEL FROM THE TOOTH CAME OFF WITH THE BRACKET. AFTER FURTHER DISCUSSION WITH THE ORTHODONTIST, IT WAS CONFIRMED THAT THE PATIENT BIT DOWN ON A SPORTS MOUTHGUARD WHICH RESULTED IN THE BRACKET COMING OFF AND DENTIN BEING EXPOSED.