DURALOC 2247-12-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295108054), received between Jun 18, 2018 and Aug 19, 2022 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT THE LINER CUT, DEEP SCRATCHES. FOUND WHEN SET RETURNED TO THE OFFICE FOR INSPECTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258086 ↗
• MalfunctionJun 18, 2018Break; Break

  IT WAS REPORTED THAT THE APEX SCREW BROKE OFF OF THE 52 MM X 32 MM + 4 MM DURALOC LINER TRIAL. WE WERE TRYING TO ADJUST IT PRIOR TO THE CASE STARTING AND IT CRACKED OFF FROM THE REST OF THE TRIAL. THIS PRODUCT WAS NOT INSERTED INTO THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7611241 ↗