Cannulated Screw System + 04.354.350Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810040632631), received between May 1, 2025 and May 1, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionMay 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025 WHILE SURGEON WAS IMPLANTING A 3.5X50MM CSS+ SCREW IN A YOUNG PATIENT WITH GOOD BONE. OUTER CORTEX AND INITIAL 1CM OF BONE WAS DRILLED WITH 2.7MM DRILL AS PER TECHNIQUE. THE SCREW WAS PLACED OVER 1.4MM WIRE AND SURGEON ATTEMPTED TO INSERT UNDER POWER. HALFWAY THROUGH TRAJECTORY, A LOUD CRACKING SOUND WAS HEARD AND THE SCREW STOPPED ADVANCING. AN X RAY SHOT WAS TAKEN AND THE SCREW HAD FRACTURED RIGHT AT THE JUNCTION BETWEEN THE SMOOTH BARREL OF THE SCREW AND THE THREADED PORTION. THE FOLLOWING 45 MINUTES WERE SPENT RETRIEVING THE BROKEN PORTION OF THE SCREW THAT WAS EMBEDDED IN THE PATIENT. WAS DIFFICULT TO REMOVE FRACTURED SCREW PIECE, HAD TO TREPHINE OUT THE BONE AROUND SCREW, FRAGMENT WAS SUCCESSFULLY REMOVED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943164 ↗