N/A 8450107030DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327134650), received between May 29, 2018 and Jul 26, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398742 ↗
• MalfunctionJun 30, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE IN THE ATTACHMENT DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS A MICRO ENDOSCOPIC DISCECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092056 ↗
• MalfunctionMay 29, 2018Break; Break

  IT WAS REPORTED THAT DURING AN MED (MICRO ENDOSCOPIC DISCECTOMY) PROCEDURE, THE BUR BROKE ALONG THE SHAFT. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550183 ↗