DURALOC 2220-36-458Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295102618), received between Oct 6, 2017 and Dec 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 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.

• MalfunctionDec 30, 2021Break; Break

  THE LINER TRIAL THREAD INSERT IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119021 ↗
• MalfunctionApr 4, 2019Detachment of Device or Device Component; Scratched Material; Detachment of Device or Device Component; Scratched Material

  IT WAS REPORTED THAT THE CENTER, METAL PIECE OF THE LINERS HAS CAME OUT. THIS DID NOT OCCUR DURING SURGERY, THEREFORE NO PIECES NEEDED TO BE RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484072 ↗
• MalfunctionOct 6, 2017Break; Break

  IT WAS REPORTED THAT UPON POST-SURGICAL EVALUATION, LINER SCREW WAS FOUND TO BE LOOSE AND SEPARATED FROM THE LINER LATER ON THE OBSERVATION.

  Patient problems: No Information

  MAUDE report 6922164 ↗