AOS PROXIMAL HUMERAL PLATE 8 HOLE 3012-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665006360), received between Nov 22, 2023 and Feb 2, 2024 — classified as 1 injury, 1 malfunction.

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

• 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. T HE 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; Pain

  MAUDE report 18634023 ↗
• MalfunctionNov 22, 2023Inadequacy of Device Shape and/or Size; Defective Device; Inadequacy of Device Shape and/or Size; Defective Device

  ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3012-008 PROXIMAL HUMERAL PLATE DISTAL LOCKING HOLES SEEMED TO BE CROSSED-THREADED AND DID NOT ACCEPT MULTIPLE 8114-028 CORTICAL SCREWS. WHEN THE SCREWS WERE IMPLANTED, THEY WOULD SPIN IN PLACE AND WENT RIGHT THROUGH THE PLATE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERAL FRACTURE PROCEDURE ON 10/24/2023. ADDITIONAL INFORMATION RECEIVED ON 10/30/2023: THE CASE WAS COMPLETED USING A 3012-011 PROXIMAL HUMERAL PLATE WITH MULTIPLE 8114-028 CORTICAL SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 18192114 ↗