AXSOS 661428SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540686367), received between Jan 5, 2017 and Jan 24, 2019 — classified as 1 injury, 1 malfunction.

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 16, 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.

• MalfunctionJan 24, 2019Break

  SCREW BREAKAGE OCCURRED DURING AXSOS OPERATION. ACCORDING TO 2.5 MM DRILL AFTER PRE-DRILL, THEN INSERTING THE SCREW BASED ON THE PROCEDURE MANUAL. HOWEVER IT GOT HARDER ON THE WAY AND STOPPED MOVING. WHEN FURTHER TIGHTENING BY PUTTING IN FORCE, IT BROKE AT THE SHAFT OF THE SCREW. THE BROKEN SCREW END WAS REMAINED IN PATIENT BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8276290 ↗
• InjuryJan 5, 2017Device Slipped

  THE UPPER LIMB CONSULTANT, REPORTED THAT AN AXSOS III PROXIMAL LATERAL HUMERAL PLATE HAD FAILED/PULLED OFF FROM A PATIENT. THE PATIENT WAS REVISED. IT WAS FURTHER REPORTED THAT HE HAD TORQUED THE LOCKING SCREWS AND THAT HE DID NOT THINK THE BONE WAS OF POOR QUALITY. THE SURGEON WAS UNSURE WHETHER THE PATIENT HAD BEEN COMPLIANT. ORIGINAL FRACTURE LEFT PROXIMAL HUMERAL SHAFT (B)(6) 2015. TYPICAL NONUNION. ENDS FRESHENED. ROUTINE FOLLOW-UP. PATIENT REPRESENTED ON (B)(6) 2016 WITH PLATE PULLED OFF. SURGEON HAS CONFIRMED THAT THE PATIENT WAS INITIALLY TREATED NONOPERATIVELY IN A BRACE AND DEVELOPED A NONUNION.

  Patient problems: Failure of Implant

  MAUDE report 6226036 ↗