CORTICAL BONE SCREW 3.5mm x 35mm 8110-035Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848665034110), received between Oct 3, 2022 and Jul 24, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/27/2025, A PATIENT'S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A COMMINUTED FRACTURE OF THE LEFT HUMERAL NECK ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING COMPLICATIONS, INCLUDING PERSISTENT PAIN, NONUNION OF THE FRACTURE, AND SIGNIFICANT DISCOMFORT WITH ANY MOVEMENT OF THE LEFT SHOULDER. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT A TARGETER/DRILL GUIDE HAD BEEN INADVERTENTLY RETAINED FROM THE INITIAL PROCEDURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE RETAINED INSTRUMENT, DEBRIDE THE INFECTED AREA, AND REPLACE THE SURGICAL HARDWARE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, THE FOLLOWING COMPONENTS WERE REMOVED: ONE 3022-005 PROXIMAL HUMERAL PLATE; TWO 8110-032 CORTICAL SCREWS; TWO 8110-035 CORTICAL SCREWS; ONE 8110-040 CORTICAL SCREW; ONE 8110-045 CORTICAL SCREW; ONE 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW; ONE 8124-044 FULLY THREADED CANCELLOUS LOCKING SCREW; THREE 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREWS; TWO 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREWS; AND ONE 8124-050 FULLY THREADED CAN

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 22586234 ↗
• InjuryJul 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 6/27/2025, A PATIENT'S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A COMMINUTED FRACTURE OF THE LEFT HUMERAL NECK ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING COMPLICATIONS, INCLUDING PERSISTENT PAIN, NONUNION OF THE FRACTURE, AND SIGNIFICANT DISCOMFORT WITH ANY MOVEMENT OF THE LEFT SHOULDER. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT A TARGETER/DRILL GUIDE HAD BEEN INADVERTENTLY RETAINED FROM THE INITIAL PROCEDURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE RETAINED INSTRUMENT, DEBRIDE THE INFECTED AREA, AND REPLACE THE SURGICAL HARDWARE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, THE FOLLOWING COMPONENTS WERE REMOVED: ONE 3022-005 PROXIMAL HUMERAL PLATE; TWO 8110-032 CORTICAL SCREWS; TWO 8110-035 CORTICAL SCREWS; ONE 8110-040 CORTICAL SCREW; ONE 8110-045 CORTICAL SCREW; ONE 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW; ONE 8124-044 FULLY THREADED CANCELLOUS LOCKING SCREW; THREE 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREWS; TWO 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREWS; AND ONE 8124-050 FULLY THREADED CAN

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Unspecified Infection

  MAUDE report 22586170 ↗
• MalfunctionOct 3, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO 8110-035 CORTICAL SCREWS BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: Insufficient Information

  MAUDE report 15534190 ↗