SIGMA LCS 9505-01-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295226048), received between Oct 24, 2017 and Nov 2, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TOWER WAS BENT AND WOULD NOT SECURELY FIT INTO CUTTING BLOCK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715496 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE. DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428836 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE. DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428835 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE. DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428829 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428623 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428612 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428591 ↗
• MalfunctionMar 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TEETH OF THE ALIGNMENT TOWER THAT SLIDE INTO THE BLOCK WERE BENT FROM REGULAR USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428578 ↗
• MalfunctionSep 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE ALIGNMENT TOWER WOULD NOT SLIDE INTO CUTTING SLOT IN TIBIAL CUTTING GUIDE AS IS TYPICAL TECHNIQUE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7855031 ↗
• MalfunctionNov 21, 2017Bent; Bent

  IT WAS REPORTED THAT ONE OF THE TEETH TO THE ALIGNMENT TOWER WAS BENT. IT WAS ALSO REPORTED THAT DUE TO THE BEND IT WOULD NOT INSERT INTO THE TIBIA CUTTING BLOCK.

  Patient problems: No Information

  MAUDE report 7048626 ↗
• MalfunctionOct 24, 2017Bent; Bent

  IT WAS REPORTED THAT THE IM ROD HANDLE FLANGE BENT DURING SURGERY. WON'T FIT INTO CUTTING GUIDE CORRECTLY. IT WAS STATED THAT IT WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Information

  MAUDE report 6972657 ↗