VARIAX 629579Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327131567), received between Aug 15, 2018 and Jan 15, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Connection Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2021Fracture

  AS REPORTED: "DURING HIS VISIT TO THE CUSTOMER, OUR SALES REP BECAME AWARE OF A PLATE FRACTURE 3 MONTHS AFTER IMPLANTATION. THIS WAS RE-OPERATED WITH A SYNTHES STEEL PLATE."

  Patient problems: Failure of Implant

  MAUDE report 11181097 ↗
• InjuryNov 19, 2018Connection Problem

  TWO WEEKS AFTER AN ARTHRODESIS ON THE WRIST, IT WAS FOUND THAT THE USED SCREWS WERE NOT HELD IN THE VARIAX PLATE. THE SURGEON REPORTS THAT HE ALREADY HAD THE FEELING DURING SCREWING THAT THE LOCKING MECHANISM DOES NOT WORK PROPERLY. THE DEVICE WAS REMOVED AND WILL RETURN FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 8084206 ↗
• InjuryAug 15, 2018Insufficient Device Problem Information

  PATIENT REPORTED FEELING A POP WHEN HE WAS LATCHING THE BOAT ON HIS HITCH. THE NEXT MORNING AFTER THE POP, HE COULD NOT LIFT HIS LEFT INDEX FINGER FULLY. HE REPORTS LEFT WRIST/ HAND PAIN & SWELLING. X-RAY (B)(6)2018: FRACTURE OF LEFT WRIST ARTHRODESIS PLATE AT LEVEL OF 3RD METACARPAL BASE. NO SCREW LOOSENING. (B)(6)2018: HARDWARE REMOVED WITH FAILURE AT OBLONG HOLE". AS LISTED UNDER ADVERSE CONSEQUENCES: "LEFT INDEX EXTENSOR TENDON RUPTURE".

  Patient problems: Rupture

  MAUDE report 7784988 ↗