Spark 728-3032Recalls & reported problems
Ormco Corporation · Spark Advanced - Refinement · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00889989084863), received between Jun 4, 2024 and Jun 4, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Inflammation1
- Itching Sensation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED A PATIENT HAD ALLERGIC REACTION TO THE ALIGNERS. THE PATIENT REFERS ITCHING AT HER TONGUE, PALATE AND BUCCAL MUCOSA. SHE HAS ALSO EXPERIENCED SWELLING AND DRYNESS OF HER LIPS SINCE SHE STARTED WITH THE NEW SET OF ALIGNERS. BASED ON DOCTOR'S PROFESSIONAL OPINION, IT IS CONSIDERED A SERIOUS INJURY. THE SYMPTOMS STARTED 2 OR 3 DAYS AFTER USING THE ALIGNERS. PATIENT SEEKED MEDICAL ATTENTION WITH A DERMATOLOGIST. DIAGNOSIS WAS NOT PROVIDED. PATIENT WAS REFERRAL TO A MAXILOFACIAL SURGEON. PATIENT WILL HAVE A FOLLOW UP VISIT IN ONE (1) WEEK. IT WAS PRESCRIPTED ACYCLOVIR. NO INFORMATION WAS PROVIDED IF PATIENT IS FULLY RECOVERED.
Patient problems: Inflammation; Itching Sensation
MAUDE report 19464162 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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