AXSOS 627484SRecalls & reported problems
Stryker GmbH · Distal Anterolateral Tibia Plate · 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 07613327082173), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Failure of Implant1
- Injury1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2019Fracture; Break; Fracture; Device Dislodged or Dislocated
AS REPORTED: "TREATED AN EMERGENCY WITH THE ANKLE JOINT OPEN AND DISLOCATED, AND LOWER IT. ON (B)(6) 2019, THE INTERNAL FIXATION WAS ADDED. SINCE THE SECOND HALF OF THE YEAR HAS PASSED, HE WAS OVERLOADED. A FOLLOW-UP EXAMINATION CONFIRMED THE BREAKAGE. IT WAS A FUSION FAILURE. SCHEDULED FOR RE-OPERATION ON (B)(6) 2019."
Patient problems: Failure of Implant; Injury; No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 9313524 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- 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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