AXSOS 661046SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540708786), received between Nov 28, 2016 and Jul 29, 2020 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJul 29, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: "EVENT DETAILS: WHEN FIXING THE SCREW TO THE PLATE, IT WAS CONFIRMED THAT THERE WAS METAL LINT. PHYSICIAN'S POINT OF VIEW: THE SCREWS WERE INSERTED AT A DIFFICULT ANGLE, SO THE METALS RUBBED AGAINST EACH OTHER AND WERE SCRAPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10339751 ↗
• MalfunctionMay 11, 2020Fracture; Fracture

  AS REPORTED: "THE X-RAY SHOWED THAT THE SCREWS WERE BROKEN. THE FRACTURE IS GOOD, THEY LET THE SCREWS SIT FIRST."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10045499 ↗
• InjuryNov 28, 2016Device Dislodged or Dislocated

  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 TORQUE 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.

  Patient problems: No Code Available

  MAUDE report 6130561 ↗