CARRIERE SLX 3D
Received Sep 29, 2023 · Event occurred Jan 19, 2023
Report 2081322-2023-00003 · MDR key 17847057
Device
Generic name
Orthodontic Metal Brackets
Manufacturer
Ortho Organizers, Inc.Model number
777-LR4-HK-10Catalog number
777-LR4-HK-10
Product problems
- Sharp Edges
- Sharp Edges
Patient
38 YR · Female
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
THE CARRIERE SLX 3D BRACKETS ARE STAINLESS STEEL, PASSIVE, SELF-LIGATING ORTHODONTIC BRACKETS THAT DIRECTLY BOND TO THE TEETH TO PROVIDE A TREATMENT SOLUTION FOR PATIENTS WITH MALOCCLUSIONS OF PRIMARY, PERMANENT, OR MIXED DENTITION. IT WAS REPORTED IN THE CUSTOMER COMPLAINT FORM THAT BRACKET LR4 HAD SHARP EDGES CAUSING CHEEK IRRITATION, CUTTING THE CHEEK ON THE LOWER RIGHT OF THE PATIENT AND CAUSING LARGE SORES THAT DID NOT HEAL. THE SYMPTOMS BEGAN THE DAY AFTER THE BRACKET WAS PLACED. THE BRACKET NEEDED TO BE REMOVED AND REPLACED WITH A DIFFERENT BRAND. THE 38-YEAR OLD FEMALE PATIENT WAS PRESCRIBED KENALOG IN ORABASE, A TOPICAL STEROID. SHE WAS ALSO ADVISED TO TAKE OTC PAIN MEDICATION SUCH AS IBUPROFEN AND TYLENOL. DUE TO THE FACT THAT PRESCRIPTION AND OTC MEDICATIONS WERE GIVEN, ORTHO ORGANIZERS DECIDED TO REPORT THIS COMPLAINT TO THE FDA.
Description of Event or Problem
IT WAS REPORTED IN THE CUSTOMER COMPLAINT FORM THAT BRACKET LR4 HAD SHARP EDGES CAUSING CHEEK IRRITATION, CUTTING THE CHEEK ON THE LOWER RIGHT OF THE PATIENT AND CAUSING LARGE SORES THAT DID NOT HEAL. THE SYMPTOMS BEGAN THE DAY AFTER THE BRACKET WAS PLACED. THE BRACKET NEEDED TO BE REMOVED AND REPLACED WITH A DIFFERENT BRAND. THE 38-YEAR OLD FEMALE PATIENT WAS PRESCRIBED KENALOG IN ORABASE, A TOPICAL STEROID. SHE WAS ALSO ADVISED TO TAKE OTC PAIN MEDICATION SUCH AS IBUPROFEN AND TYLENOL.