AXSOS 627203Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327091069), received between Oct 4, 2019 and Oct 4, 2019 — classified as 2 malfunctions.

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

• MalfunctionOct 4, 2019Material Rupture

  CUSTOMER NOTICED, THAT THE THREADS OF ATTACHMENT OF THE ROTATOR CUFF IN THE PROXIMAL HUMERUS, WHICH ARE PULLED THROUGH THE PLATES, RUPTURE. IT IS AN AXSOS3 PROXIMAL HUMERAL PLATE. UNFORTUNATELY, THERE IS NO SPECIFIC INFORMATION AS TO WHICH PLATE IS USED. NO SPECIFIC EVENT KNOWN. GENERAL COMPLAINT. IT MAY AFFECT THE FOLLOWING ITEMS: FROM 627203 TO 627250S. SALES REP CONFIRMED THAT SURGEON USES ARTHREX THREADS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159302 ↗
• MalfunctionOct 4, 2019Material Rupture

  CUSTOMER NOTICED, THAT THE THREADS OF ATTACHMENT OF THE ROTATOR CUFF IN THE PROXIMAL HUMERUS, WHICH ARE PULLED THROUGH THE PLATES, RUPTURE. IT IS AN AXSOS3 PROXIMAL HUMERAL PLATE. UNFORTUNATELY, THERE IS NO SPECIFIC INFORMATION AS TO WHICH PLATE IS USED. NO SPECIFIC EVENT KNOWN. IT IS A GENERAL COMPLAINT. SALES REP CONFIRMED THAT SURGEON USES ARTHREX THREADS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159300 ↗