VARIAX 40-20807Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252222002), received between Apr 23, 2018 and Oct 6, 2021 — classified as 2 injuries.

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

Recent adverse event reports

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

• InjuryOct 6, 2021Fracture; Fracture

  AS REPORTED: "INITIAL PROCEDURE IS (B)(6) 2020. IMPLANTED PLATE. LAG SCREW 18MM FOR PROXIMAL AND DISTAL PIECES. 2 FIBER WIRES USED FOR 3RD BONE PIECE. 18 MM NON-LOCKING IN THE ELLIPTICAL HOLE, AND LOCKING SCREWS ARE USED FOR ALL OTHER HOLES. POSTOPERATIVE REHABILITATION: 4 WEEKS UNLOADED, 6 WEEKS FULL WEIGHT. THE PATIENT COMPLAINED A PAIN ON (B)(6) 2021. PROXIMAL LOCKING RUPTURE + PLATE DEFLECTION WERE OCCURRED ON (B)(6) 2021. BROKEN THE PLATE WERE OCCURRED ON (B)(6) 2021. THE PATIENT UNDERWENT A REVISION SURGERY."

  Patient problems: Failure of Implant; Implant Pain; Limb Fracture

  MAUDE report 12582857 ↗
• InjuryApr 23, 2018Break; Off-Label Use

  PATIENT BROKE HER ARM AND HAD TO HAVE SURGERY. THE REP GAVE THE DOCTOR THE WRONG PLATES. HE GAVE HIM PLATES FOR THE ANGLE AND THESE WENT INTO HER ARM. HER ARM CONTINUED TO HURT AND IN FEBRUARY SHE HAD X-RAYS DONE AND IT WAS FOUND THAT THE PLATES WERE BROKEN AND THE PLATES GIVEN TO THE DOCTOR WERE FOR THE ANKLE. ADDITIONAL INFORMATION: MAUDE REPORT (MW5075607) WAS RECEIVED BY STRYKER T AND E AND REVIEWED FOR THE EVENTS THE PATIENT DESCRIBED. HAD REPAIR OF BROKEN FEMUR AND RADIUS WITH STRYKER METAL PLATES ON (B)(6) 2017 AND ON (B)(6) 2018 AFTER HAVING SUFFERED PAIN AND NOTICED DEFORMITY OF MY ARM XRAYS SHOWED BOTH PLATES WERE BROKEN AND BONES WERE BROKEN AGAIN. WAS TOLD BY MY MD THAT HE SPOKE WITH STRYKER REP AND HE WAS TOLD THAT REP HAD GIVEN HIM THE WRONG PLATES AND I UNDERWENT 2ND SURGERY ON (B)(6). HAD BROKEN PLATES REMOVED AND NEW ONES PUT IN PLACE. HAVE NEW STAINLESS STEEL PLATES.

  Patient problems: Pain

  MAUDE report 7452123 ↗