Spark 728-3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889989083460), received between May 22, 2020 and Feb 18, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT BEGAN TREATMENT WITH SPARK ALIGNERS AND, AFTER TWO MONTHS OF USE, DEVELOPED SIGNIFICANT CRACKING OF THE ANTERIOR TEETH. DUE TO THE SEVERITY OF THE FRACTURES, THE AFFECTED TEETH WILL REQUIRE EXTRACTION.

  Patient problems: Tooth Fracture

  MAUDE report 24381658 ↗
• InjuryDec 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT HAD A SEVERE ALLERGIC REACTION. PATIENT EXPERIMENTED SEVERE SWELLING OF UPPER AND LOWER LIPS FOUR (4) DAYS AFTER STARTING THE FIRST ALIGNER OF THE INITIAL SET. BASED ON DOCTOR'S PROFESSIONAL OPINION, ALLERGIC REACTION IS CONSIDERED ADVERSE EVENT BECAUSE IF THE PATIENT CONTINUE WITH WEARING THE ALIGNERS THE ALLERGY COULD WORSEN. PATIENT DID NOT SEEK MEDICAL ATTENTION WITH A DOCTOR AND DID NOT GO TO HOSPITAL FOR THESE SYMPTOMS. PATIENT TOOK A HEAVY DOSE OF BENADRYL TO REDUCE THE SWOLLEN OF THE LIPS. DOCTOR REQUESTED THE PATIENT NOT TO WEAR THE ALIGNERS AND THE SYMPTOMS DISAPPEAR. PATIENT IS FULLY RECOVERED BUT CURRENTLY IS NOT WEARING THE ALIGNERS.

  Patient problems: Local Reaction

  MAUDE report 18368708 ↗
• InjurySep 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT DEVELOPED A SEVERE MEDICAL COMPLICATION FROM AN ALLERGIC RESPONSE TO THE ALIGNERS. PATIENT FIRST REPORTED SENSATION OF TINGLING AND BITTERNESS TASTE IN HER TONGUE AFTER 2 DAYS OF WEARING ALIGNERS. DOCTOR SUGGESTED HER TO WEAR THE ALIGNERS FOR A FULL WEEK SINCE THERE IS AN ADJUSTMENT PERIOD TO ALIGNERS. AFTER 1 WEEK OF WEARING THEM, PATIENT REPORTED THAT HER SYMPTOMS HAD NOT IMPROVED. BUT WORSENED. PATIENT LOOKED FOR MEDICAL ATTENTION WITH A FAMILIAR MEDICINE DOCTOR FOR THIS REACTION. THE DIAGNOSIS WAS EDEMA OF THE EPIGLOTTIS FROM ALLERGIC REACTION. IT WAS PRESCRIBED ZYRTEC AND THE PATIENT IS FULLY RECOVERED.

  Patient problems: Local Reaction

  MAUDE report 17844450 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS AN ANGIOEDEMA DIAGNOSIS AND HAS SWELLING IN HER MOUTH WHEN WEARING THE SPARK ALIGNERS.

  Patient problems: Swelling

  MAUDE report 10083283 ↗