VariAx 53-27214ERecalls & reported problems
Stryker GmbH · BONE SCREW, T7 · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154914005), received between Sep 14, 2015 and Apr 9, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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.
Most reported problems
Device problems
- Defective Device1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2018Fracture
IT WAS REPORTED FROM DISTRIBUTOR BIOMED ELECTRONIQUE, THE FOLLOWING EVENT FOR DR (B)(6). FROM THE (B)(6) CLINIC : "DURING IMPLANTATION WITHOUT USING FORCE, FRACTURE OF THE SCREW AT THE HEAD AND THREAD JUNCTION. SURGEON HAD TO LEAVE THE SCREW THREAD.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7409594 ↗MalfunctionSep 14, 2015Defective Device
DURING THE MEDICAL PROCEDURE IT WAS NOTICED BY THE SURGEON, THAT THE SCREW HAS A SMALL DEFECT IN THE BODY WHICH DOES NOT ALLOW IT TO GO THROUGH THE PLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5076510 ↗
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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.
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