n.a. 484242Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551253229), received between Mar 19, 2025 and Mar 19, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Break; Break

  IT WAS REPORTED THAT THE END OF THE OSTEOTOME BROKE OFF WHILST EMBEDDED IN THE NASAL BONE LEAVING A FRAGMENT IN THE PATIENT. X-RAY WAS REQUIRED. PROCEDURE COMPLETED SUCCESSFULLY WITH PROLONGATION OF 15-60 MINUTES. REPORTED PATIENT OUTCOME: FINE. IT IS STILL UNDER CLARIFICATION IF THE METAL FRAGMENT WILL BE RETRIEVED AND HOW LONG WAS THE EXACT PROLONGATION TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21647638 ↗
• InjuryMar 19, 2025Break; Break

  IT WAS REPORTED THAT A FRACTURED END OF OSTEOTOME WITH FRAGMENT OF METAL (< 2 MM) LEFT IN PATIENT'S NASAL BONE. X-RAY WAS REQUIRED. PROCEDURE COMPLETED SUCCESSFULLY WITH PROLONGATION OF 15-60 MINUTES. REPORTED PATIENT OUTCOME: FINE. IT IS STILL UNDER CLARIFICATION IF THE METAL FRAGMENT WAS RETRIEVED / WILL BE RETRIEVED AND HOW LONG WAS THE EXACT PROLONGATION TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21647619 ↗
• InjuryMar 19, 2025Break; Break

  IT WAS REPORTED THAT A FRACTURED END OF OSTEOTOME WITH FRAGMENT OF METAL (< 2 MM) LEFT IN PATIENT'S NASAL BONE. X-RAY WAS REQUIRED. PROCEDURE COMPLETED SUCCESSFULLY WITH PROLONGATION OF 15-60 MINUTES. REPORTED PATIENT OUTCOME: FINE. IT IS STILL UNDER CLARIFICATION IF THE METAL FRAGMENT WAS RETRIEVED / WILL BE RETRIEVED AND HOW LONG WAS THE EXACT PROLONGATION TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21647517 ↗
• InjuryMar 19, 2025Break; Break

  IT WAS REPORTED THAT THE END OF THE OSTEOTOME BROKE OFF WHILST EMBEDDED IN THE NASAL BONE LEAVING A FRAGMENT IN THE PATIENT. X-RAY WAS REQUIRED. PROCEDURE COMPLETED SUCCESSFULLY WITH PROLONGATION OF 15-60 MINUTES. REPORTED PATIENT OUTCOME: FINE. IT IS STILL UNDER CLARIFICATION IF THE METAL FRAGMENT WILL BE RETRIEVED AND HOW LONG WAS THE EXACT PROLONGATION TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 21647443 ↗