PROFORM
Received Nov 26, 2025
Report 3010002722-2025-00004 · MDR key 23660343
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Inflammation
- Inflammation
Narrative
Additional Manufacturer Narrative
KEYSTONE INDUSTRIES RECEIVED A COMPLAINT FROM A DENTIST OFFICE ON (B)(6) 2025. THE PRODUCT WAS IDENTIFIED AS ".060 SPLINT PROFORM (25)", ITEM NUMBER 9614960. THE DENTAL ASSISTANT REPORTS, ON (B)(6) 2025 PATIENT HAD A DENTAL IMPLANT SURGERY. THE .060 SPLINT MATERIAL WAS USED AS AN ORTHODONTIC TYPE RETAINER TO PROTECT THE IMPLANT. SEVERAL DAYS LATER PATIENT EXPERIENCED FACIAL SWELLING AND REDNESS IN CHEEKS AFTER THE PROCEDURE. THE PATIENT RECEIVED AN ANTIBIOTIC FROM A FAMILY DOCTOR. PATIENT IMPROVED WITH ANTIBIOTIC. IT IS NOTED THAT THE PATIENT ALSO HAD A TOOTH EXTRACTED. PATIENT HAS NOT STOPPED WEARING APPLIANCE. THERE WAS NO LOT NUMBER PROVIDED WITH THE COMPLAINT. IT IS UNKNOWN WHO THE VENDOR OF THE MATERIAL IS.
Description of Event or Problem
A DENTAL PROFESSIONAL CONTACTED KEYSTONE INDUSTRIES REGARDING AN EVENT WHERE A PATIENT HAD A DENTAL IMPLANT SURGERY ON (B)(6) 2025 AND USED THE .060 SPLINT MATERIAL AS AN ORTHODONTIC TYPE RETAINER TO PROTECT THE DENTAL IMPLANT. SEVERAL DAYS LATER THE PATIENT EXPERIENCED FACIAL SWELLING AND REDNESS IN CHEEKS. PATIENT RECEIVED ANTIBIOTIC FROM FAMILY DOCTOR. PATIENT IMPROVED WITH ANTIBIOTIC AND HAS NOT STOPPED WEARING THE .060 SPLINT DEVICE. IT IS NOTED THAT THE PATIENT ALSO HAD A TOOTH EXTRACTED.