SIGMA 96-3332Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295246220), received between Jul 5, 2018 and Jul 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2018Break; Break

  IT WAS REPORTED THAT 2 115 X 12 STEM TRIALS BROKE WHILE IMPACTING, ALL PARTS RETRIEVED. IT WAS ALSO INDICATED THAT THE 2.5 X 12 MM INSERT TRIAL METAL POST BENT. NO SURGICAL DELAY. PARTS WILL BE RETURNED. EXAMINATION OF THE FOUR RETURNED TC3 RP TIB INS TRL CONFIRMED THE PIN COMPONENTS HAVE PARTIALLY MIGRATED OUT OF THE TRIAL BODIES RESULTING IN A TILTED POSITION. THERE IS RANDOM SIGNIFICANT SCARRING AND GOUGING. THE OVERALL CONDITION OF THE DEVICES INDICATE MODERATE USAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7663648 ↗