AXS 56-17906Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · BONE SCREWS, AXS, SELF-DRILLING · Class 2 · Implant
Data updated Oct 13, 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 37613327358385), received between Feb 28, 2023 and Feb 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE SAW BLADE CAUGHT IN THE GUIDE RESULTING IN A VIBRATION. THE VIBRATION CAUSED THE FIXATION SCREWS TO RELEASE AND TWO OF THE SCREWS CAME OUT OF THE SURGICAL SITE, POSING THE RISK OF A MATERIAL BEING LOST IN A SURGICAL SITE. ONE SCREW WAS LOCATED IN THE ORAL CAVITY AND THE OTHER SCREW WAS LOCATED POST OPERATIVELY WHEN THE DRAPING WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16454690 ↗
Other PLATE, BONE devices
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- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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