VARIAX 657414Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327073782), received between May 13, 2019 and Apr 3, 2024 — classified as 6 injuries, 1 malfunction.

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

• InjuryApr 3, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING MATERIAL REMOVAL SURGERY , THE SCREW HEAD DISASSEMBLED FROM THE SCREW BODY, NOT BEING ABLE TO REMOVE IT. SINCE IT WAS A TRICORTICAL SCREW THE HEAD OF THE SCREW BREAKS AND THE SCREW CANNOT BE REMOVED FROM PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 19038424 ↗
• MalfunctionMar 16, 2021Material Fragmentation; Material Fragmentation

  AS REPORTED: "DURING A VARIAX 2 PLATE PROCEDURE WITH A 3.5MM CORTICAL SCREW (INSERTED USING A HAND SCREWDRIVER) A METAL FILAMENT OUTSIDE THE SCREW OR PLATE WAS DEVELOPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499247 ↗
• InjuryNov 23, 2020Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AS REPORTED: "A (B)(6)-YEAR-OLD FEMALE PT UNDERWENT THE CLAVICLE JOINT SURGERY (LEFT) ON (B)(6) 2020. AFTER THE OPERATION, THE PLATE MOVED AND THE SCREW CAME OFF THE PLATE, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020."

  Patient problems: Failure of Implant

  MAUDE report 10884977 ↗
• InjuryJul 30, 2019Detachment of Device or Device Component

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Code Available

  MAUDE report 8842473 ↗
• InjuryJul 29, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8839432 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.

  Patient problems: Reaction

  MAUDE report 8605925 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.

  Patient problems: Reaction

  MAUDE report 8605920 ↗