SIGMA 9505-02-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295228516), received between Oct 6, 2020 and Oct 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE FOLLOWING ITEMS ARE STARTING TO LOOK WORN, TIRED AND IN NEED OF REPLACEMENT. NO DELAYS TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664416 ↗
• MalfunctionOct 6, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO PLACE A DRILL PIN THROUGH THE +2 POSTERIOR REFERENCING DRILL HOLE AS THE METAL SURROUNDING THE DRILL HOLE HAS BECOME WARPED DUE TO REPEATED USE. THE METAL WAS BLOCKING THE DRILL PIN FROM GOING THROUGH THE DRILL HOLE. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10639121 ↗