CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 34mm 8114-034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665033458), received between Feb 21, 2022 and Dec 30, 2024 — classified as 2 malfunctions.

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

• MalfunctionDec 30, 2024Break; Break

  ON 12/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8114-034 DOUBLE LEAD LOCK CORTICAL SCREW HEAD BROKE OFF IN AN ALPHA PLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037951 ↗
• MalfunctionFeb 21, 2022Break

  ON 2/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) 8114-034 SCREW AND AN 8114-036 SCREW BROKE INSIDE THE PATIENT. DURING A 3 PART HUMERAL FRACTURE WITH THE HEAD IN VARUS, SURGEON SPENT ALMOST AN HOUR TRYING TO REDUCE THE FRACTURE AND GET GOOD HEAD AND TUBEROSITY POSITION. PLATE WAS APPLIED AND SECURED WITH K-WIRES. ALIGNMENT GUIDE WAS ATTACHED TO PROXIMAL CLUSTERS AND PLATE WAS REPOSITIONED TWICE TO LOWER CONSTRUCT. THE 4.0 FULLY THREADED CANCELLOUS SCREWS WERE USED FIRST IN THE HUMERAL HEAD. THE SLEEVE/THREADED GUIDE COMBO WERE USED IN EACH HOLE AND A T15 DRIVER WAS USED MANUALLY. ALL SCREWS WERE IMPLANTED SUCCESSFULLY. THE MOST INFERIOR HOLE (KICKSTAND SCREW) WAS SWITCHED TO THE PARTIALLY THREADED 4.0MM CANCELLOUS SO THE DRILL WAS CHANGED FROM THE BLUE 2.5 TO THE GOLD 3.5 GRADUATED DRILL, AND THE THREADED GUIDE WAS CHANGED FROM BLUE TO GOLD. SURGEON TURNED TO THE PLATE SHAFT PRIOR TO ALL PROXIMAL HOLES BEING FILLED AND USED THE 2.5 GREEN DRILL AND THE HAND HELD DRILL GUIDE. THE LOCKING END NESTLED INTO THE PLATE HOLE AND DRILL WAS USED BICORTICALLY. DEPTH WAS READ OFF DRILL CALIBRATION AND THE SCREW WAS PUT ON THE RATCHETING BLACK HANDLE/T15 DRIVER. SCREW W

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13569434 ↗