VariAx 656312SRecalls & reported problems
Stryker GmbH · Locking Screw, Fully Threaded,T8 · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327070675), received between Dec 16, 2020 and Nov 17, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (3 reports).
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
- Positioning Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A LOCKING FAILURE OCCURRED. THE 1ST AND 2ND LOCKING SCREWS WERE USED; HOWEVER, THEY DID NOT LOCK INTO THE PLATE. CORTICAL SCREWS WERE USED AT THE HOLES. ALTHOUGH A MALFUNCTION OF THE PLATE LOCKING MECHANISM WAS CONSIDERED, THE PLATE WAS NOT REPLACED BECAUSE THREE SCREWS HAD ALREADY BEEN INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23575609 ↗MalfunctionNov 17, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A LOCKING FAILURE OCCURRED. THE 1ST AND 2ND LOCKING SCREWS WERE USED, HOWEVER THEY DID NOT LOCK INTO THE PLATE. CORTICAL SCREW WERE USED AT THE HOLES. ALTHOUGH A MALFUNCTION OF THE PLATE LOCKING MECHANISM WAS CONSIDERED, THE PLATE WAS NOT REPLACED BECAUSE THREE SCREWS HAD ALREADY BEEN INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23573895 ↗MalfunctionDec 16, 2020Positioning Failure; Positioning Failure
AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE.". ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR.". SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11016249 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, 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.
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