ULTRAPOWER 00702129400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854007532), received between Nov 2, 2023 and Nov 2, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• MalfunctionNov 2, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00702129400, ULTRAPOWER BUR, ROUND END (MUSTARD) WAS BEING USED ON (B)(6) 2023 AND ¿IT WAS REPORTED THAT THIS BUR BROKE SHORTLY AFTER IT WAS PUT INTO USE¿¿. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BACKUP BUR. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058633 ↗