VariAx 53-27614SRecalls & reported problems
Stryker GmbH · LOCKING SCREW, T7 · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540593962), received between Apr 21, 2021 and Nov 14, 2023 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Implant Pain1
- Loss of Range of Motion1
- Pain1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IN 2018, THE CLAIMANT HAD AN ORIF AND WAS IMPLANTED WITH UNKNOWN PINS AND A PLATE, AROUND DECEMBER 2021/JANUARY 2022, SHE FELT SOME DISCOMFORT/IRRITATION AND SOUGHT MEDICAL CARE. THE REVISION WAS SCHEDULED FOR JUNE 2022 TO REMOVE THE IMPLANTED DEVICES. DURING THE SURGERY, THE SURGEON DISCOVERED THAT HE DID NOT HAVE THE CORRECT INSTRUMENTS TO REMOVE THE HARDWARE. THE HOSPITAL SPENT SOME TIME TRYING TO FIND A SUITABLE TO ASSIST IN THE REMOVAL, BUT COULD NOT LOCATE A SUITABLE SCREWDRIVER. HOWEVER, ONE SCREW WAS ABLE TO BE REMOVED THROUGH CAREFUL USE OF A SMALLER SCREWDRIVER HEAD. SINCE THE FAILED SURGERY, THE PATIENT HAS BEEN LEFT WITH A RAISED RED RASH ON HER WRIST, AND IS IN MORE PAIN THAN BEFORE THE FAILED SURGERY. ADDITIONALLY, THIS IS AFFECTING HER WRIST MOVEMENT MORE THAT BEFORE THE SURGERY.
Patient problems: Implant Pain; Loss of Range of Motion; Skin Inflammation/ Irritation
MAUDE report 18132907 ↗MalfunctionApr 21, 2021Migration; Migration
THE PATIENT COMPLAINED OF PAIN WHICH FOUND OUT BACK OUT OF THE SCREW FROM THE PLATE. REMOVAL OF THE SCREW WAS SCHEDULED FOR (B)(6) 2021. THERE WAS A POSSIBILITY THAT SCREW WAS NOT LOCKING TO THE PLATE.
Patient problems: Pain
MAUDE report 11704190 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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