CORTICAL BONE SCREW 3.5mm x 22mm 8110-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848665033182), received between Feb 2, 2024 and Feb 2, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT WHO UNDERWENT A PROCEDURE WHERE ARTHREX DEVICES WERE IMPLANTED WAS EXPERIENCING A PAINFUL REACTION. THE INITIAL PROCEDURE OCCURRED ON (B)(6) 2023. THE PATIENT BEGAN TO EXPERIENCE PAIN 3-4 WEEKS POST. THE PATIENT WAS REFERRED TO A PAIN SPECIALIST WHO SUGGESTED SHE WAS HAVING AN ALLERGIC REACTION AS THE SCAR WAS RED AND PUFFY. SHE NOTED SHE FEELS TERRIBLE PAIN AND THROBBING, AND WHEN ATTEMPTING TO LIFT, IT'S PAINFUL. THE SURGEON MENTIONED SHE COULD HAVE THE DEVICES REMOVED IN 6 MONTHS FROM HER SURGERY DATE. HOWEVER, SHE IS NOT SURE SHE CAN TAKE THE PAIN THAT MUCH LONGER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain

  MAUDE report 18632557 ↗