VARIAX 629590Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327131536), received between Jun 25, 2019 and Jun 29, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A VARIAX 2 WRIST PLATE WAS REVISED DUE TO THE PLATE BEING BROKEN.

  Patient problems: Failure of Implant

  MAUDE report 14852320 ↗
• InjuryJun 25, 2019Break

  AS REPORTED ON MEDWATCH (B)(4) "THE PATIENT HAD A LEFT WRIST ARTHRODESIS PROCEDURE PERFORMED ON [...] WITH AUTOLOGOUS BONE GRAFT AND FIXATION USING A STRYKER WRIST FIXATION PLATE. THE PATIENT RETURNED FOR EVALUATION ~3 YEARS LATER CITING TWO WEEKS OF INCREASING LEFT WRIST PAIN AND SWELLING ON LEFT DORSAL DISTAL FOREARM AND DORSAL WRIST. THE PATIENT ALSO NOTED NUMBNESS OF THE INDEX, MIDDLE AND RING FINGER. AN X-RAY REVEALED FRACTURE OF THE RADIAL METACARPAL PLATE THROUGH THE SCREW HOLE AT THE CARPAL METACARPAL JOINT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM 6 DAYS LATER FOR REMOVAL OF THE BROKEN PLATE AND 8 SCREWS. A BONE GRAFT WAS COMPLETED. THE PATIENT WILL HAVE A CAST FOR 4-6 WEEKS AND LIMITED LIFTING CAPABILITY. THERE WAS NO PATIENT FALL OR TRAUMA THAT COULD BE ATTRIBUTED TO THE PLATE FRACTURE. THE SURGEON THOUGHT THAT THE PLATE BREAKAGE WAS METAL FATIGUE LIKELY DUE TO MICROMOTION OF THE MIDDLE FINGER (3RD DIGIT) CARPOMETACARPAL (CMC) JOINT."

  Patient problems: Numbness; Pain; Swelling

  MAUDE report 8732136 ↗