CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 28mm 8124-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665033571), received between Feb 2, 2024 and Dec 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Break; Break

  ON 10/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3024-01 11-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 REVISION SURGERY IS STILL TO BE DETERMINED. 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: DURING THE INITIAL SURGERY ON (B)(6) 2024, A 3024-011 11-HOLE LEFT ALPHA PLATE, TWO 8110-026 CORTICAL BONE SCREW, AN 8110-028 CORTICAL BONE SCREW, THREE 8110-030 CORTICAL BONE SCREWS, AN 8114-024 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-028 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8114-030 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-028 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, FULLY THREADED, AN 8124-038 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREW, AN 8124-050 FULLY THREADED CANCELLOUS LOCKING SCREW, A

  Patient problems: Failure of Implant

  MAUDE report 20914882 ↗
• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 01/19/2024, 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 18633335 ↗