VARIAX 657310Recalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327086782), received between Sep 19, 2018 and Aug 4, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (5 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 Failure5
- Appropriate Device Problem Term/Code Not Available1
- Biocompatibility1
Patient problems
- No Known Impact Or Consequence To Patient6
- No Clinical Signs, Symptoms or Conditions4
- Erosion1
- Foreign Body Reaction1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2025Biocompatibility; Biocompatibility
AS REPORTED: "SURGEON ADVISED HE WAS REMOVING ONE OF OUR VARIAX FIBULA PLATES THAT HE HAD IMPLANTED 5 YEARS PRIOR & AT THE PLATE BONE INTERFACE AS PER ATTACHED PHOTO THERE WAS "GROSS METALLOSIS" AND "PRETTY BAD BONE EROSION" PLATE AND SCREWS HAVE BEEN SUCCESSFULLY REMOVED & WILL BE RETURNED ONCE DECONTAMINATED. SWABS HAVE BEEN SENT TO LOCAL PATHOLOGY."
Patient problems: Erosion; Foreign Body Reaction
MAUDE report 22699857 ↗MalfunctionJul 15, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED: THERE WAS NO LOCKING IN THE PLATE WITH SEVERAL VARIAX2 LOCKING SCREWS 10MM 3.5 T10. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE AFFECTED SCREWS AND USING VARIAX1 SCREWS INSTEAD. SURGICAL DELAY OF 20MIN. NOT LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10278902 ↗MalfunctionJul 15, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED: THERE WAS NO LOCKING IN THE PLATE WITH SEVERAL VARIAX2 LOCKING SCREWS 10MM 3.5 T10. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE AFFECTED SCREWS AND USING VARIAX1 SCREWS INSTEAD. SURGICAL DELAY OF 20MIN. NOT LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10278302 ↗MalfunctionJul 15, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED: THERE WAS NO LOCKING IN THE PLATE WITH SEVERAL VARIAX2 LOCKING SCREWS 10MM 3.5 T10. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE AFFECTED SCREWS AND USING VARIAX1 SCREWS INSTEAD. SURGICAL DELAY OF 20MIN. NOT LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10278275 ↗MalfunctionJul 15, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED: THERE WAS NO LOCKING IN THE PLATE WITH SEVERAL VARIAX2 LOCKING SCREWS 10MM 3.5 T10. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE AFFECTED SCREWS AND USING VARIAX1 SCREWS INSTEAD. SURGICAL DELAY OF 20MIN. NOT LONGER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10278268 ↗MalfunctionJul 15, 2020Positioning Failure; Positioning Failure
IT WAS REPORTED: THERE WAS NO LOCKING IN THE PLATE WITH SEVERAL VARIAX2 LOCKING SCREWS 10MM 3.5 T10. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REMOVING THE AFFECTED SCREWS AND USING VARIAX1 SCREWS INSTEAD. SURGICAL DELAY OF 20MIN. NOT LONGER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10278222 ↗MalfunctionSep 19, 2018Appropriate Device Problem Term/Code Not Available
PRIMARY PROCEDURE, RIGHT CLAVICLE. IT WAS REPORTED THAT IN IMPLANTING THE VARIAX2 CORE 3.5 LOCKING SCREWS INTO THE CLAVICULAR PLATE, THE SCREWS WOULD NOT LOCK - THEY KEPT SPINNING WHEN THEY SHOULD HAVE LOCKED. REP OBTAINED LOCKING SCREWS FROM A VARIAX 1 ANKLE SOLUTION SET, WHICH LOCKED AS EXPECTED. THE PLATE IS IMPLANTED AND THE REPORTED SCREWS ARE AVAILABLE FOR RETURN. REP REPORTED THAT SURGEON WAS FOLLOWING THE SURGICAL TECHNIQUE THROUGHOUT THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 5 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7891485 ↗
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- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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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