AXSOS 627233SRecalls & reported problems
Stryker GmbH · Proximal Lateral Humerus Plate, RIGHT · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327091243), received between Oct 28, 2020 and Sep 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Malposition of Device1
- Material Integrity Problem1
- Positioning Failure1
Patient problems
- Failure of Implant1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2025Malposition of Device; Malposition of Device
AS REPORTED: "PATIENT UNDERWENT ORIF FOR HUMERAL FRACTURE ON (B)(6) 2025. AXSOS PH IMPLANTED. THE PATIENT HAD TO UNDERGO REVISION SURGERY DUE TO RE-DISLOCATION OF THE BONY FRAGMENT OF THE GREATER TUBEROSITY OF THE HUMERUS DUE TO MALPOSITIONING OF THE PLATE."
Patient problems: Joint Dislocation
MAUDE report 23144615 ↗InjuryAug 27, 2021Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
IT WAS REPORTED THE HOLES FOR K-WIRE/SUTURE ON A STRYKER PROXIMAL HUMERUS PLATE HAVE A FIBER WIRE TORN/SNAPPED. THE DEVICE WAS IMPLANTED ON TUBERCLE MINUS TO FIX/FIXATE ON THE PROXIMAL HUMERUS. THE ISSUE WAS OBSERVED DURING A REVISION SURGERY PERFORMED ON (B)(6) 2021. THE REVISION SURGERY WAS PERFORMED BECAUSE DURING THE PRIMARY OPERATION THE REPOSITION OF THE FRAGMENTS NEEDED TO BE DONE AGAIN.
Patient problems: Failure of Implant
MAUDE report 12377684 ↗MalfunctionOct 28, 2020Positioning Failure; Positioning Failure
AS REPORTED: "THE THIRD ROW FROM THE PROXIMAL POSITION, BUT IT DID NOT LOCK AND I REINSERTED ANOTHER LOCKING SCREW, BUT IT DID NOT LOCK. AFTER ALL, THE SCREW WAS INSERTED WITHOUT LOCKING. OTHER SCREW HOLES ARE FINE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10748749 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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