AXSOS 661424Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252580331), received between Apr 28, 2022 and Mar 3, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (3 reports).

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.

• InjuryMar 3, 2026Fracture

  AS REPORTED: "A REVISION SURGERY HAD TO BE PERFORMED USING SYNTHES. THE PATIENT HAD TO HAVE ANOTHER SURGERY. THE PLATE FAILED ACCORDING TO SURGEON AND A LOCKING SCREW PULLED THROUGH THE PANGEA DISTAL HUMERUS PLATE.

  Patient problems: Insufficient Information

  MAUDE report 24495335 ↗
• InjuryMay 16, 2023Break; Fracture; Break; Fracture

  AS REPORTED: PT BROKE THEIR RIGHT HUMERUS AND WAS COMPLIANT TO ALL MOBILITY INSTRUCTIONS. PATIENT WENT TO BED AND WOKE UP THE FOLLOWING MORNING AND EXPERIENCED PAIN IN THEIR ARM AND KNEW THAT SOMETHING WAS WRONG. WENT INTO THE HOSPITAL, X-RAYS WERE TAKEN AND IT WAS CONFIRMED THAT THE SCREW HEADS WERE BROKEN WITHIN 3-4 WEEKS POST OP. THE HEADLESS SCREWS WERE LEFT IN BUT THE PLATE AND REMAINING SCREWS WERE REMOVED. PATIENT WAS REVISED AND IS HAVING NO ISSUES WITH THE PLATE.

  Patient problems: Failure of Implant; Foreign Body In Patient; Implant Pain

  MAUDE report 16939473 ↗
• MalfunctionApr 28, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT THERE WAS SCREW BREAKAGE DURING PLACEMENT WITH USE OF DYNAMO. THE REST OF THE SCREW WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14236711 ↗