AXSOS 627204SRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327091106), received between Jul 29, 2020 and Jul 29, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionJul 29, 2020Material Fragmentation; Material Fragmentation
AS REPORTED: "EVENT DETAILS: WHEN FIXING THE SCREW TO THE PLATE, IT WAS CONFIRMED THAT THERE WAS METAL LINT. PHYSICIAN'S POINT OF VIEW: THE SCREWS WERE INSERTED AT A DIFFICULT ANGLE, SO THE METALS RUBBED AGAINST EACH OTHER AND WERE SCRAPED."
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10339750 ↗
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- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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