CHS 71970533Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010415301), received between Dec 16, 2019 and Dec 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 16, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, THE PLATE WOULD NOT FIT OVER THE LAG SCREW. THE LAG SCREW WAS REMOVED AND THE SURGEON STILL HAD DIFFICULTY GETTING THE PLATE TO FIT OVER THE SCREW. THE SCREW WAS ONCE AGAIN INSERTED AND EVENTUALLY FORCED OVER LAG SCREW. THERE WAS A DELAY OVER 30 MINUTES DUE TO THIS ISSUE. NO PATIENT INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9474119 ↗