CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 36mm 8114-036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665033465), received between Feb 21, 2022 and Nov 27, 2024 — classified as 1 injury, 1 malfunction.

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.

• InjuryNov 27, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-016 16-HOLE LEFT ALPHA PLATE BROKE POSTOPERATIVELY THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH THE PLATE, AND ON (B)(6) 2024, THE PLATE WAS REMOVED. PER THE SALES REPRESENTATIVE, THE PATIENT DID NOT REPORT ANY FALLS OR INJURIES. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 11/13/2024: THE CORRECT ORIGINAL SURGERY DATE IS (B)(6) 2024. THE PATIENT WAS IMPLANTED WITH THE 3024-016 16-HOLE LEFT ALPHA PLATE, AN 8110-026 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREWS, FOUR 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-036 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-030 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-036 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-042 FULLY THREADED CANCELLOUS LOCKING SCREW, TWO AR-7268T TIGERTAPE CERCLAGE WITH FIBERLINK SHUTTLE SUTURE, AND AN ABS-2010-10 ALLOSYNC PURE. DURING THE REVISION SURGERY, ALL THE HARDWARE WAS REMOVED. THE REVISION SURGERY WAS COMPLETED USI

  Patient problems: Failure of Implant

  MAUDE report 20790429 ↗
• MalfunctionFeb 21, 2022Break

  ON (B)(6) 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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13569448 ↗