WG-99 LT Synea Fusion Contra-angle Handpiece 30007000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J021300070001), received between Jun 9, 2026 and Jun 9, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Detachment of Device or Device Component

  CROWN LENGTHENING SURGERY ON PALATAL ASPECT OF TOOTH 15 WAS HAPPENING. THE ENTIRE BUR (TUNGSTEN CARBIDE ROUND BUR HM1/5, HAGER & MEISINGER GMBH) DISLODGED OUT OF THE HANDPIECE AND FELL IN THE THROAT. THE PATIENT WAS IMMEDIATELY NOTIFIED AND AT COMPLETION OF THE PROCEDURE WAS IMMEDIATELY SENT FOR RADIOGRAPHS TO SEE WHETHER IT HAD ENTERED THE CHEST OR STOMACH. LATER IT WAS FOUND FROM THE RADIOGRAPHS THAT BUR WAS LOCATED IN THE PATIENT'S CHEST. PATIENT WAS THEN REFERRED TO THE RESPIRATORY TEAM AT (B)(6) HOSPITAL FOR FURTHER MANAGEMENT. UNFORTUNATELY, AFTER AN ATTEMPT AT BRONCHOSCOPY THE TIP OF THE BUR WAS VISIBLE BUT WAS UNABLE TO BE RETRIEVED, SO THE TEAM ELECTED TO LEAVE IT IN PLACE AND MONITOR FOR SYMPTOMS.

  Patient problems: Aspiration/Inhalation

  MAUDE report 25443755 ↗