3M¿ CLARITY¿ ADVANCED CERAMIC BRACKETS, APC¿ FLASH-FREE
Received Mar 12, 2025 · Event occurred Jan 7, 2025
Report 2020467-2025-00002 · MDR key 21588949
Device
Generic name
Bracket, Ceramic, Orthodontic; Adhesive, Bracket And Tooth Conditioner, Resin
Manufacturer
3m Unitek CorporationModel number
4006-350Catalog number
4006-350
Lot number
NI
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Tooth Fracture
- Tooth Fracture
Narrative
Additional Manufacturer Narrative
MDR 2020467-2025-00002 SUBMITTED ON 12-MAR-2025 NOTED THE FOLLOWING: SECTION B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT: BLANK. SECTION B5 DESCRIBE EVENT OR PROBLEM: PHYSICIAN REPORTED¿ CORRECTIONS: SECTION B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE(DEVICES). SECTION B5 DESCRIBE EVENT OR PROBLEM: AN ORTHODONTIST REPORTED¿
Description of Event or Problem
AN ORTHODONTIST REPORTED THE PATIENT ALLEGEDLY HAD ATTRITION ON THE UPPER TEETH THAT WERE HITTING THE LOWER 3M¿ CLARITY¿ ADVANCED CERAMIC BRACKETS. THE ATTRITION OCCURRED ON THE UPPER CENTRAL AND LATERAL INCISORS. RESTORATIONS WERE REQUIRED FOR 4 TEETH TO REPAIR THE ATTRITION AND RESTORE TEETH TO ORIGINAL STATE.
Additional Manufacturer Narrative
NO SAMPLE WAS RETURNED FOR ANALYSIS AND NO LOT NUMBER WAS PROVIDED; THEREFORE, CAUSE AND TIMING OF THE ATTRITION COULD NOT BE DETERMINED. SOLVENTUM WILL CONTINUE TO MONITOR.
Description of Event or Problem
PHYSICIAN REPORTED THE PATIENT ALLEGEDLY HAD ATTRITION ON THE UPPER TEETH THAT WERE HITTING THE LOWER 3M CLARITY ADVANCED CERAMIC BRACKETS. THE ATTRITION OCCURRED ON THE UPPER CENTRAL AND LATERAL INCISORS. RESTORATIONS WERE REQUIRED FOR 4 TEETH TO REPAIR THE ATTRITION AND RESTORE TEETH TO ORIGINAL STATE.