Spark 728-3020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889989083453), received between Nov 8, 2023 and Mar 20, 2024 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT FELT INTENSE PAIN THAN USUAL IN THE AREA OF THE LEFT UPPER INCISORS, THE SYMPTOMS STARTED WHEN PATIENT USED ALIGNER STAGE 14. DURING THE USED OF ALIGNER STAGE 15, THE LEFT INCISOR BEGAN TO BE VERY SENSITIVE TO THE COLD AND CAUSED SEVERE PAIN. PATIENT VISITED THE ORTHODONTIST AND DID NOT IDENTIFY ANY ANOMALY AND RECOMMENDED MOVING FORWARD WITH THE TREATMENT AND CHANGING STAGE AS PLANNED. THE STRONG SENSITIVITY ON TOOTH CONTINUED BUT SUBSEQUENTLY DISAPPEARED. 2 WEEKS LATER, THE LEFT INCISOR BEGAN TO CHANGE COLOR TURNING GREY. PATIENT VISITED THE GENERAL DENTIST AND DIAGNOSIS IMMINENT NECROSIS OF THE TOOTH AND PROBLEM TO BE RESOLVED WITH DEVITALIZATION AND RECOLORING OF THE TOOTH.

  Patient problems: Necrosis

  MAUDE report 18944885 ↗
• InjuryNov 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED PATIENT HAD AN ALLERGIC REACTION TO THE FIRST SET OF ALIGNERS. SYMPTOMS PATIENT EXPERIENCED WERE NOT PROVIDED. BASED ON DOCTOR'S PROFESSIONAL OPINION ALLERGIC REACTION CAN BE A SERIOUS INJURY FOR POSSIBLE ANAPHYLAXIS. PATIENT DID NOT GO TO THE HOSPITAL AND WAS NOT REFERRAL TO ANOTHER TYPE OF DOCTOR. PATIENT IS FULLY RECOVERED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18095481 ↗