TG-97 LM Synea Fusion Highspeed Handpiece 30006000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J021300060001), received between Mar 4, 2024 and Mar 4, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE DOCTOR WAS PREPPING POSTERIOR TOOTH WITH W&H HIGH SPEED TG-97 LM USING A 330 CARBIDE BUR. WHILE CUTTING THE CROWN WITH THE HIGHSPEED HANDPIECE THE BUR SLIPPED OUT OF THE HANDPIECE, PAST THROUGH THE DRY SHIELD DOWN THE PATIENTS THROAT. THE PROCEDURE WAS IMMEDIATELY STOPPED AND THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM. THE PERSONNEL OF THE EMERGENCY ROOM SENT HIM TO THE HOSPITAL AND AFTER LOCATING THE BUR IN HIS STOMACH BY X-RAY, THE PATIENT HAD AN EMERGENCY ENDOSCOPY WHERE THE BUR WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826043 ↗