Spark 728-3031Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889989084856), received between Oct 4, 2023 and Oct 4, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD PAIN IN THE LL ANTERIOR REGION AND ALSO HAD MIGRAINES. UPON EXAMINATION THE DOCTOR DIAGNOSED AN ABSCESS IN THE #22 AREA WITH SIGNIFICANT FACIAL MOVEMENT IN THAT AREA AND SIGNIFICANT BONE LOSS. DOCTOR RECOMMENDED TO PATIENT TO STAY IN CURRENT ALIGNERS AND NOT MOVE FORWARD UNTIL INFECTION CLEARS AND DOCTOR SPEAK WITH SPARK RE ABOUT THE MOVEMENTS FOR THIS PATIENT. PATIENT EXPERIMENTED THE FOLLOWING SYMPTOMS: PAIN IN #22 AREA, SWELLING, IRRITATION, SEVERE HEADACHES, TOOTH MOBILITY AND SEVERE BONE LOSS. IN DOCTOR OPINION, THIS COMPLAINT WOULD IT LIKELY CAUSE A SERIOUS INJURY BECAUSE THE PATIENT WOULD BE PRONE TO ANOTHER INFECTION AND SUFFER PERMANENT TOOTH LOSS IN #22 OR EVEN ALL OF HER LOWER ANTERIOR TEETH. PATIENT STARTED SPARK ALIGNERS ON (B)(6) 2022. HER FIRST REFINEMENT WAS DELIVERED ON (B)(6) 2023 AND SHE WAS GIVEN ALIGNERS STAGES 1 TO 7 OF 1 WEEK. PATIENT CAME BACK ON (B)(6) 2023 AND WAS GIVEN ALIGNERS STAGES 8 TO 14 AND CALLED ON (B)(6) 2023 AND WAS ON ALIGNER STAGE 14 AT THAT POINT. IT WAS PRESCRIBED CLINDAMYCIN AND SRP WITH MINOCYCLINE PLACEMENT. PATIENT IS NOT FULLY RECOVERED BECAUSE PAIN AND HEADACHES HAVE SUBSIDED BUT DOCTOR IS EXTREMELY CONCE

  Patient problems: Abscess

  MAUDE report 17870867 ↗