AXSOS 661026Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252579786), received between May 2, 2018 and Sep 21, 2018 — classified as 2 injuries.

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

• InjurySep 21, 2018Migration or Expulsion of Device

  THE PATIENT WAS TREATED WITH A AXSOS PHL PLATE ON (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN DURING HER FOLLOW-UP VISIT ON (B)(6) 2018. SCREWS OF THE PLATE HAD EMIGRATED. THE PATIENT HAD TO BE OPERATED AGAIN.

  Patient problems: Pain

  MAUDE report 7899273 ↗
• InjuryMay 2, 2018Device Slipped

  IT WAS REPORTED THAT FEMALE PATIENT BORN ON (B)(6) FELL DOWN AT HOME (B)(6) 2018. ARRIVED IN HOSPITAL (B)(6) 2018 AND IT WAS NOTICED THAT SHE HAS RIGHT PROXIMAL HUMERUS FRACTURE. PATIENT SMOKES ½-1 PACKETS OF CIGARETTES PER DAY, HYPERTENSION, DMII, HYPERCHOLESTEROLEMIA, PRIMARY HYPERALDOSTERONISM, PALMOPLANTA PUSTULOSIS. PATIENT WAS OPERATED (B)(6) 2018. AXSOS 3 PROX. HUMERUS PLATE WITH 4 HOLES WAS IMPLANTED. PROXIMALLY THERE WERE 7 LOCKING SCREWS IMPLANTED AND DISTALLY 2 LOCKING SCREWS AND 2 BONE SCREWS. THE SURGERY WENT THROUGH SMOOTHLY. AT 5.2, THE PATIENT FELT A CLICK ON THE SHOULDER AND CONTACTED THE HOSPITAL. PATIENT WAS ASKED TO FOLLOW THE SITUATION AT HOME. PAIN INCREASED AND 7.2 PATIENT COMES TO FIRST AID. NEW RTG IMAGE WERE TAKEN 7.2 AND 8.2 CT. THE DISTAL SCREWS OF THE PLATE ARE LOOSE, WAITING FOR REVISION OPERATION. SALES REP HAS ASKED THE HOSPITAL TO RETURN THE PLATE AND SCREWS TO STRYKER FOR INVESTIGATION. PRODUCT NUMBERS ARE NOT AVAILABLE AT THIS POINT. ITEMS WILL BE ADDED TO THIS PI ONCE INFORMATION RECEIVED FROM HOSPITAL. PAIN, UPCOMING REVISION.

  Patient problems: Pain

  MAUDE report 7481200 ↗