AXSOS 661046Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252579885), received between May 2, 2018 and Oct 24, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2018Fracture

  THE HOSPITAL REPORTED THE FOLLOWING EVENT : "DURING RADIOGRAPHIC INSPECTION AT 9 MONTHS OF OSTEOSYNTHESIS SHOWS A PSEUDOSEPTIC OSTEOARTHRITIS OF THE LEFT TIBIA WITH FRACTURE OF THE OSTEOSYNTHESIS PLATE (PLACED ON (B)(6) 2018 FOLLOWING AN OPEN FRACTURE IN THE LEFT LEG). PROVISIONAL MEASURES AND ACTIONS TAKEN: NEED FOR SURGICAL RESUMPTION ON (B)(6) 2018 WITH REMOVAL OF THE MATERIAL, SAMPLES, FIRST TIME MASK WITH SPACER IN CEMENT FIXATION BY EXTERNAL FIXATOR AND ANTIBIOTIC THERAPY. THE DEVICE HAS BEEN RETAINED FOR EXPERTISE. CLINICAL CONSEQUENCES NOTED: NEED FOR SURGICAL RESUMPTION AND SEPTIC PSEUDARTHROSIS."

  Patient problems: Bone Fracture(s)

  MAUDE report 8002697 ↗
• InjuryMay 2, 2018Device Slipped

  IT WAS REPORTED THAT FEMALE PATIENT BORN ON 1942 FELL DOWN AT HOME 28.1.2018. ARRIVED IN HOSPITAL 29.1.2018 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 31.1.2018. 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.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 7481290 ↗
• InjuryMay 2, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT FEMALE PATIENT BORN ON 1942 FELL DOWN AT HOME (B)(6)2018 . ARRIVED IN HOSPITAL 29.1.2018 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.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: Bone Fracture(s); Fall; Pain

  MAUDE report 7481254 ↗
• InjuryMay 2, 2018Loose or Intermittent Connection; Noise, Audible

  IT WAS REPORTED THAT FEMALE PATIENT (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.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: Failure of Implant; Pain

  MAUDE report 7481132 ↗