Spark 728-3022Recalls & reported problems
Ormco Corporation · Spark 20 / Active - Refinement · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889989084832), received between Dec 18, 2023 and Dec 18, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION TO TRUGEN XR ALIGNERS. PATIENT EXPERIMENTED EYES SWOLLEN AND WATER SINCE 1ST DAY WEARING THE ALIGNERS. BASED ON DOCTOR'S PROFESSIONAL OPINION, IT IS CONSIDERED SERIOUS INJURY DUE TO THE PATIENT HAD EYES SWOLLEN. IT WAS PRESCRIPTED ANTIHISTAMINE. PATIENT IS FULLY RECOVERED. THE PROBLEM WAS WITH TRUGEN X MATERIAL USED IN REFINEMENT, PATIENT DIDN'T PRESENT ANY ALLERGIC REACTION WITH TRUGEN MATERIAL. RE-ORDER WAS MADE WITH TRUGEN MATERIAL TO CONTINUE WITH TREATMENT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 18352251 ↗
Other Aligner, Sequential devices
- Byte Day Alignes HBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,719 reports
- Byte Night Aligners NBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,053 reports
- sequential aligner 100-0352Access Dental Lab, LLC · Aligner, Sequential322 reports
- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.