P.F.C. SIGMA 96-1906Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295240457), received between May 30, 2018 and May 6, 2022 — classified as 6 malfunctions.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT DURING SURGERY THAT THE TWO SZ 5 X 4MM POSTERIOR AUGMENT TRIALS ARE DAMAGED. ONE HAS BEEN REPORTED BY STERIS AS DAMAGED & NOT PUT BACK ON THE SET AND THE OTHER IS AVAILABLE FOR RETURN. THE ONE ON THE SET DOESN¿T CLIP TO THE FEMORAL TRIAL AND FALLS OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304267 ↗
• MalfunctionApr 29, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT DURING SURGERY THAT THE TWO SZ 5 X 4MM POSTERIOR AUGMENT TRIALS ARE DAMAGED - ITEM CODE 961906. ONE HAS BEEN REPORTED BY STERIS AS DAMAGED & NOT PUT BACK ON THE SET AND THE OTHER IS AVAILABLE FOR RETURN. THE ONE ON THE SET DOESN¿T CLIP TO THE FEMORAL TRIAL AND FALLS OFF. THIS CAN BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253750 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT THE POST ON THE POSTERIOR AUGMENT TRIAL BROKE. NO PROBLEMS AND NO TIME EXTENDED. ALL PIECES WERE RETRIEVED FROM THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274330 ↗
• MalfunctionJul 26, 2019Break; Break

  PEG BROKE FROM SIZE 5/4MM POSTERIOR AUGMENT TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830782 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED THAT THE AUGMENTS BROKE DURING TRIALING PROCESS. NO SURGICAL DELAY. ALL PIECES RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553286 ↗
• MalfunctionMay 30, 2018Break; Break

  IT WAS REPORTED THAT THE AUGMENTS BROKE DURING TRIALING PROCESS. NO SURGICAL DELAY. ALL PIECES RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7553266 ↗