KEYSPLINT HARD

Additional Manufacturer Narrative

ON (B)(6) 2024, KEYSTONE INDUSTRIES WAS NOTIFIED BY A PATIENT OF AN ADVERSE EVENT INVOLVING ONE OR MORE DEVICES MANUFACTURED FROM THE COMPANY'S 3D KEYPRINT RESIN PRODUCTS. THE PATIENT INITIALLY CONTACTED IMAGINE DENTAL, A DENTAL OFFICE LOCATED IN CALGARY, ALBERTA, CANADA, WHICH SUBSEQUENTLY FORWARDED THE REPORT TO KEYSTONE INDUSTRIES. A REFERENCE NUMBER WAS NOT PROVIDED. A LOT NUMBER WAS PROVIDED BUT DOES NOT EXIST IN KEYSTONES SYSTEM. THE PATIENT ALSO REPORTED HAVING A SEPARATE REACTION TO ANOTHER SIMILAR DEVICE, KEYSPLINT SOFT, WHICH REQUIRED MEDICAL INTERVENTION. REFERENCE 3010002722-2025-00002. BOTH EVENTS OCCURRED IN CANADA AND WERE PREVIOUSLY REPORTED TO HEALTH CANADA ON (B)(6) 2024. THE ADVERSE EVENT INVOLVING THE KEYSPLINT HARD DEVICE IS NOW BEING REPORTED TO THE FDA RETROACTIVELY, FOLLOWING CLARIFICATION OF FDA REQUIREMENTS FOR REPORTING ADVERSE EVENTS OCCURRING OUTSIDE OF THE UNITED STATES.

Description of Event or Problem

PATIENT REPORTED A REACTION WITH KEYSPLINT HARD, THAT RESULTED IN SWELLING OF THE MOUTH AND THROAT (MOST PREDOMINANTLY UPPER LIP WHERE THE MOUTH GUARD TOUCHED).