VariAx 57-15392Recalls & reported problems
Stryker GmbH · 2.3 M VARIAX HAND LOCK 3-D PLATE · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154496761), received between Feb 18, 2020 and Mar 23, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Material Twisted/Bent1
Patient problems
- Failure of Implant1
- 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.
InjuryMar 23, 2022Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "A VARIAX HAND PLATE WAS IMPLANTED 6 WEEKS AGO. SKIN IRRITATION/INFLAMMATION OCCURRED IN THE AREA OF THE PLATE. AFTER TREATMENT WITH CORTISONE FAILED, THE SURGEON REMOVED THE IMPLANTS."
Patient problems: Skin Inflammation/ Irritation
MAUDE report 13857964 ↗InjuryFeb 18, 2020Material Twisted/Bent; Material Twisted/Bent
THE PATIENT REPORTS THAT ON (B)(6) 2019, SHE WAS IMPLANTED WITH A STRYKER VARIAX 3D PLATE 2.3MM 4X2HOLE AS A RESULT OF A CORRECTIVE OSTEOTOMY WITH BONE GRAFT IMPLANT ON THE THIRD METACARPAL OF THE RIGHT HAND. THE PATIENT WAS URGED TO AVOID PRESSURE AND CARRYING SO THAT THE SCREWS WOULD NOT TEAR OUT. IN THE MEANTIME THE PLATE HAS BENT AND A CORRESPONDING HUMP HAS FORMED IN THE BACK OF HER HAND: 20° PLATE, 30° BONE BEND UNDERNEATH. THE PATIENT COMPLAINS OF PAIN. AT THE MOMENT NO FURTHER INFORMATION IS AVAILABLE ABOUT THE HOSPITAL WHERE THE IMPLANTATION WAS PERFORMED ON (B)(6) 2019.
Patient problems: Failure of Implant; Pain
MAUDE report 9721594 ↗
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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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