AXSOS 661134SRecalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of AXSOS (184)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540686114), received between Feb 21, 2020 and Apr 30, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem3
- Migration1
Patient problems
- Implant Pain3
- Nonunion/Delayed-union Bone Fracture3
- Failure of Implant1
- Injury1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT HAD A DISTAL FEMORAL GMRS REVISION. REASON FOR REVISION WAS PATIENT PAIN AND INCORRECTLY HEALED FRACTURE."
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture
MAUDE report 19217593 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT HAD A DISTAL FEMORAL GMRS REVISION. REASON FOR REVISION WAS PATIENT PAIN AND INCORRECTLY HEALED FRACTURE."
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture
MAUDE report 19217398 ↗InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: PATIENT WAS REVISED. PATIENT PAIN AND INCORRECTLY HEALED FRACTURE.
Patient problems: Implant Pain; Nonunion/Delayed-union Bone Fracture
MAUDE report 19217389 ↗InjuryFeb 21, 2020Migration; Migration
AS REPORTED: "A PATIENT WHO UNDERWENT A PLATE FIXATION PROCEDURE ON (B)(6) 2019 COMPLAINED OF PAIN. WHEN THE X-RAY WAS TAKEN, THE PROXIMAL PART OF THE PLATE FLOATED AWAY FROM THE BONE. THEN, ON (B)(6) 2020, THE PLATE WAS REMOVED AND FIXED WITH K WIRES."
Patient problems: Failure of Implant; Injury; Pain
MAUDE report 9742089 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page