VARIAX 657324SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327086997), received between Feb 10, 2020 and Dec 22, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "THREADED PIECES OF METAL APPEARED WHEN TIGHTENING A SCREW TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387223 ↗
• MalfunctionJun 16, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "POOR LOCKING OF PLATE AND SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148192 ↗
• MalfunctionOct 20, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING SCREWS DID NOT ENGAGE WITH CLAVICLE LOCKING PLATE AND LOCK AS DESIGNED. SCREWS WERE LEFT IN PLACE - SCREWS KEPT ROTATING WHEN THEY SHOULD HAVE LOCKED." THERE WAS A 5 MINUTE SURGICAL DELAY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15642240 ↗
• MalfunctionNov 9, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THERE WERE THREE SCREWS THAT DID NOT LOCK, AND EACH TIME THE SURGEON HAD THEM REPLACED WITH SCREWS OF THE SAME SIZE OR 2 MM SHORTER. THE REPLACED SCREWS LOCKED WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779200 ↗
• MalfunctionApr 21, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE SCREW LOST A METAL PART/SPLINTERED WHILE FIXING THE PLATE ON THE BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704193 ↗
• MalfunctionAug 17, 2020Defective Device; Defective Device

  AS REPORTED: "THE HEXLOBULAR INTERNAL WAS NOT MADE ON SCREW HEAD AND THE SCREW COULD NOT BE USED. THE NEW ONE WAS USED FOR THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10417414 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  AS REPORTED: "IN 2006 MAYO PLATE WAS USED FOR NONUNION FRACTURE OF THE DISTAL HUMERUS. ON (B)(6) 2019, MAYO PLATE WAS REMOVED, AND MEDIAL AND LATERAL VARIAX ELBOW PLATE WAS IMPLANTED. TWO WEEKS AFTER REVISION SURGERY, BACK-OUT HAPPENED. (1 PROXIMAL LOCKING SCREW, 2 PROXIMAL CORTICAL SCREW, MOST DISTAL LOCKING SCREW OF LATERAL PLATE)". NO ADDITIONAL SURGERY IS PLANNED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9690393 ↗