NA 245.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982169501), received between Jan 28, 2019 and Jan 28, 2019 — classified as 1 injury.

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 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.

• InjuryJan 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF HARDWARE AND AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH A NEW LOW PROFILE RECONSTRUCTION PLATE, BONE GRAFT AND REAMER/IRRIGATOR/ASPIRATOR (RIA) DUE TO A NONUNION PELVIS AND A BROKEN DEVICE. THERE WERE FRAGMENTS THAT HAVE BEEN GENERATED AND IT WAS EASILY REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS IS STABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT INVOLVES ONE (1) 3.5MM LOW PROFILE RECONSTRUCTION PLATE 16 HOLES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8283321 ↗