P.F.C. ULTIMA 85-4673Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295208525), received between Jul 27, 2018 and Sep 14, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763997 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A INTRA OPERATIVE EVENT. THIS WAS DISCOVERED IN STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677716 ↗
• MalfunctionOct 3, 2024Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT BOTH SUMMIT CIRCULAR OSTEOTOMES WERE CHIPPED AND DULL.

  Patient problems: Insufficient Information

  MAUDE report 20359167 ↗
• MalfunctionOct 3, 2024Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT BOTH SUMMIT CIRCULAR OSTEOTOMES WERE CHIPPED AND DULL.

  Patient problems: Insufficient Information

  MAUDE report 20359159 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT THE SUMMIT BOX OSTEOTOME BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303066 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT THE SUMMIT BOX OSTEOTOME BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302999 ↗
• MalfunctionDec 7, 2022Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT CIRCULAR OSTEOTOME WAS DULL AND CHIPPED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934118 ↗
• MalfunctionMar 28, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT THE CUTTING END OF THE INSTRUMENT IS DAMAGED/WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930983 ↗
• MalfunctionApr 30, 2021Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT THE CIRCULAR BOX OSTEOTOME IS DULL AND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11756199 ↗
• MalfunctionMar 12, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CIRCULAR BOX OSTEOTOME WAS DULL AND NOT PROPERLY CUTTING. THE DOCTOR ASKED IF THIS COULD BE REPLACED. NO PIECES WERE BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476233 ↗
• MalfunctionOct 12, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE ROUND BOX OSTEOTOME IS DULL AND NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962715 ↗
• MalfunctionAug 24, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INSTRUMENT IS NOT SHARP AND BENT AROUND THE EDGES. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812816 ↗
• MalfunctionJul 27, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENT HAS BENT AROUND TOP. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726669 ↗