NA 03.605.508Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034712536), received between Sep 9, 2021 and Sep 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A LOAN SET ARRIVED AT THE LOCAL WAREHOUSE WITH AN OSTEOMA WITH A BROKEN END PIECE. THIS REPORT IS FOR AN OSTEOTOME-STRAIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336322 ↗
• MalfunctionSep 9, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PITUITARY RONGEUR STRAIGHT, DUAL-SIDED RASP BAYONETED, DEG ANGLED RASP-BAYONETED, (2) BONE CURETTE, BOX CURETTE, OSTEOTOME STRAIGHT, (2) BOX CURETTE, RINGCURETTE AND CONCORDE BONE FUNNEL WERE BROKEN. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR (1) OSTEOTOME-STRAIGHT. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450189 ↗