AXSOS 627456Recalls & 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 07613327082005), received between Aug 5, 2020 and Aug 5, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Fracture1
Patient problems
- Deformity/ Disfigurement1
- Injury1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2020Fracture; Fracture
PATIENT STATED SHE HAD A STRYKER EXTERNAL FIXATOR IMPLANTED ON LEFT ANKLE ON (B)(6) 2019 TO MOVE ANKLE OVER 30 DEGREES. ON (B)(6) 2019 THEY REMOVED THE EXTERNAL FIXATOR AND IMPLANTED AN INTERNAL FIXATOR, PLATES AND SCREWS. PATIENT WAS CLEARED FOR PHYSICAL THERAPY IN (B)(6) AND CONTINUE PT FOR TWO MONTHS. ON (B)(6) 2020 SHE WAS WALKING AROUND HER HOUSE AND HEARD A POP. PATIENT WENT TO THE URGENT CARE AND THEY TOOK X-RAYS WHICH SHOWED A BROKEN PLATE, LOOSE SCREWS AND HER ANKLE WENT BACK TO 45 DEGREES. PATIENT IS EXPERIENCING PAIN, WHICH HAS GOTTEN WORSE THESE PAST TWO WEEKS.
Patient problems: Deformity/ Disfigurement; Injury; Pain
MAUDE report 10368028 ↗
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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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