AXSOS 427010SRecalls & reported problems
Stryker GmbH · Locking Compression Plate · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 16, 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 07613154321131), received between Jun 23, 2021 and Jun 23, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Fracture1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2021Fracture; Fracture
IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON (B)(6) 2019 THE PATIENT TRIPPED, FELL, AND BROKE THE HUMERUS BONE IN HER RIGHT ARM AND UNDERWENT SURGERY ON (B)(6), 2019 WITH IMPLANTATION OF A COMPRESSION PLATE. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 SHE "WAS IN THE PROCESS OF PUSHING HER HAIR BACK BEHIND HER EAR WHEN SUDDENLY THE COMPRESSION PLATE SNAPPED, CAUSING HER HUMERUS BONE TO RE-BREAK, AND THE METAL WAS PUSHING HER BONE TO PROTRUDE OUTWARD AND CONSEQUENTLY CAUSING HER IMMENSE PAIN." ALLEGEDLY THE PATIENT UNDERWENT REVISION SURGERY TO REPAIR THE REBROKEN HUMERUS BONE AND TO REINSTALL A NEW COMPRESSION PLATE.
Patient problems: Bone Fracture(s); Failure of Implant
MAUDE report 12050046 ↗
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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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