NA 02.100.206Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982028570), received between Aug 22, 2019 and Aug 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionAug 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN THE PACKAGE WAS OPENED, THE WIDE ANGLE LOW PROFILE RECON PLATE HAD METAL SHAVING ON BONE SIDE. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RECEIVED PICTURES IT WAS IDENTIFIED THAT A FEW AREAS ON THE PLATE DO SHOW ABNORMALITIES. THIS REPORT IS FOR ONE (1) 3.5 MM WIDE ANGLE LOW PROFILE RECON PLATE 6 HOLES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8923642 ↗