LCS COMPLETION 2294-27-031Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295112945), received between May 31, 2018 and Aug 8, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2019Break; Break

  IT WAS REPORTED THAT THE LCS MED 10 MM POSTERIOR AUGMENT WAS BROKEN DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874160 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED THAT THE PEGS BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264327 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED THAT TRIAL AUGMENT BROKEN OFF. THE SET WAS A BACK UP AND NOT NEEDED. IT WAS USED DURING THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556266 ↗