AXSOS 627203SRecalls & reported problems
Stryker GmbH · Proximal Lateral Humerus Plate, LEFT · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327091038), received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED: FOR A FRACTURE OF THE PROXIMAL RIGHT HUMERUS, AXSOSPH WAS SCHEDULED TO USE AT ORIF. WHILE STERILIZING THE PATIENT WITH GENERAL ANESTHESIA, WHEN THE REPORTING SR WAS CHECKING THE IMPLANT, IT WAS NOTICED THAT THE LEFT IMPLANT WAS ARRANGED INSTEAD OF THE RIGHT ONE. SO, THE SURGEON DECIDED THE OPERATION TO BE SUSPENDED. THE CAUSE WAS THE NEGLECT OF CONFIRMATION OF THE IMPLANT BY THE DISTRIBUTOR AND HOSPITAL. THE IMPLANTS WERE IMMEDIATELY ARRANGED ON THE AFFECTED SIDE, THE OPERATION WAS RESTARTED 5 HOURS LATER, AND THE PROCEDURE COMPLETED SUCCESSFULLY. UNNECESSARY GENERAL ANESTHESIA.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10142719 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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