NA 245.914Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982170385), received between Aug 17, 2021 and Aug 17, 2021 — classified as 1 malfunction.

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 16, 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.

• MalfunctionAug 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ON (B)(6) 2021, UPON OPENING THE PACKAGE FOR A SET TO FILL IN, IT WAS NOTICED THAT THE BEND OF A LOW PROFILE CURVED RECONSTRUCTION PLATE WAS NOT CORRECT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.5MM LOW PROFILE CURVED RECON PLATE 88MM RADIUS 14 HOLES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333447 ↗