P.F.C. SIGMA 96-1053Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295234784), received between Jul 9, 2018 and Jan 10, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9577474 ↗
• MalfunctionNov 20, 2019Component Missing; Component Missing

  AN ORTHOKIT TECHNICIAN REPORTS THAT DURING THE INSPECTION AFTER THE RETURN OF THE DEVICE FROM THE HOSPITAL, HE DISCOVERED THAT TWO PCF*SIGMA PC3 WERE DEFECTIVES. THERE WERE NOT A NON-DETENT POSITION FOR THE CLAMPING SCREWS. THE DEVICES ARE NEW .THERE WERE NO PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346852 ↗
• MalfunctionJun 5, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW OF THE SIZE 3 AND 4 TC3 BOX TRIAL WAS STRIPPED. NO SURGICAL DELAY HAPPEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672053 ↗
• MalfunctionJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SET SCREW ON THE SZ 3 TC3 BOX TRIAL WAS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669842 ↗