uCentum CS 3851-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04052536081707), received between Jul 9, 2019 and Jul 9, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2019Fracture; Difficult to Remove; Fracture; Difficult to Remove

  SURGEON DECIDED TO REMOVE SYSTEM AFTER FUSION HAD OCCURRED. WHEN REMOVING THE LOCKING SCREW THE SCREWDRIVER TIP BROKE OFF IN THE LOCKING SCREW AND COULD NOT BE REMOVED. THE SURGEON HAD TO DESTROY THE SCREW HEAD TO BE ABLE TO REMOVE THE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8773544 ↗
• InjuryJul 9, 2019Fracture; Difficult to Remove; Fracture; Difficult to Remove

  SURGEON DECIDED TO REMOVE SYSTEM AFTER FUSION HAD OCCURRED. WHEN REMOVING THE LOCKING SCREW THE SCREWDRIVER TIP BROKE OFF IN THE LOCKING SCREW AND COULD NOT BE REMOVED. THE SURGEON HAD TO DESTROY THE SCREW HEAD TO BE ABLE TO REMOVE THE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8773541 ↗