X450 5HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04560264532472), received between Jan 15, 2021 and Jan 15, 2021 — 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.

• InjuryJan 15, 2021Detachment of Device or Device Component

  DOCTOR WAS ADJUSTING A CROWN WHEN THERE WAS A POPPING NOISE, AND THE HEAD CAME OFF THE BODY OF THE DEVICE INTO THE PATIENT'S MOUTH BREAKING THE INTERNAL GLASS ROD. SMALL METAL PARTS WERE OBSERVED IN THE PATIENTS MOUTH AS WELL AS PIECES FROM THE GLASS ROD. SUCTION WAS USED TO REMOVE THE PARTICLES. PATIENT DID NOT SUSTAIN ANY INJURY AND THERE WAS NO NEED FOR MEDICAL TREATMENT. A FOLLOW UP WAS CONDUCTED WITH THE PATIENT AND THERE WERE NO COMPLICATIONS FROM THE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11179757 ↗