InjuryEJF
DAMON BRACKETS
Received Feb 22, 2024 · Event occurred May 1, 2019
Report 2016150-2024-00001 · MDR key 18762304
Device
Generic name
Damon Brackets
Manufacturer
Sds De MexicoModel number
UNKNOWNCatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Prefer Not To Disclose
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
IT WAS RECEIVED A VOLUNTARY REPORT FROM FDA MDR NUMBER# MW5151054, WHERE IT IS REPORTED THAT A PATIENT HAD TEMPOROMANDIBULAR JOINT DISORDER CAUSED BY ORTHODONTIC DAMON BRACKETS. PATIENT REQUIRED INTERVENTION, HOSPITALIZATION. IT WAS REPORTED DATE OF EVENT AS 05/01/19 AND INFORM RECEIVED BY FDA ON 01/31/24. BASED ON PATIENT REQUIRED HOSPITALIZATION, IT IS CONSIDERED A SERIOUS INJURY AS DEFINED BY FDA.