VARIAX 657328Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327087031), received between Aug 5, 2020 and Sep 29, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2020Failure to Align; Failure to Align

  IT WAS REPORTED, PRIMARY HUMERAL PLATING PROCEDURE. IT WAS REPORTED THAT THE LOCKING SCREW WOULD NOT LOCK INTO THE PLATE. THE SCREW WAS REMOVED AND A SECOND LOCKING SCREW WAS USED, WHICH ALSO WOULDN'T LOCK INTO THE PLATE. THE SCREW WAS REMOVED AND THE SURGEON DECIDED THE PLATE HAD SUFFICIENT FIXATION. PATIENT WAS CLOSED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 5 MINUTES. THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10603350 ↗
• MalfunctionSep 29, 2020Failure to Align; Failure to Align

  IT WAS REPORTED, PRIMARY HUMERAL PLATING PROCEDURE. IT WAS REPORTED THAT THE LOCKING SCREW WOULD NOT LOCK INTO THE PLATE. THE SCREW WAS REMOVED AND A SECOND LOCKING SCREW WAS USED, WHICH ALSO WOULDN'T LOCK INTO THE PLATE. THE SCREW WAS REMOVED AND THE SURGEON DECIDED THE PLATE HAD SUFFICIENT FIXATION. PATIENT WAS CLOSED AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 5 MINUTES. THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10603264 ↗
• MalfunctionSep 18, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "ANGULAR STABILITY IS FUNCTIONLESS." "CHIPS HAVE COME LOOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557200 ↗
• InjuryAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THAT : INSTALLATION OF THE PLATE WITH 9 SCREWS (4 AT THE TOP AND 5 AT THE BOTTOM) IN THE PATIENT ON (B)(6) 2020 AFTER REMOVAL OF OLD EQUIPMENT FOR SEPTIC PSEUDOARTHROSIS (INITIAL MATERIAL IMPLANTED IN (B)(6) 2019 FOR FRACTURE LEFT HUMERUS) AND SUPPLY OF ILIAC GRAFT. IN POST-OPERATIVE RESIN IMMOBILIZATION ANTEBRACHIAL-PALMAR AND ANTIBIOTIC THERAPY PROBABILISTIC IV THEN RELAY PER OS ON ANTIBIOGRAM. CONTROL RADIOGRAPHY ON (B)(6) 2020 SHOWING A DISPLACEMENT OF THE SCREWS AND THE PLATE WITH PASSAGE OF 2 SCREWS THROUGH THE PLATE (UPPER PART) AND 1 SCREW OUT OF THE PLATE (UPPER PART). DECISION TO REMOVE THE MATERIAL IN THE OPERATING ROOM: OPERATION ON (B)(6) 2020 AND THE INSTALLATION OF 2 NEW PLATES AND RESIN IMMOBILIZATION ANTEBRACHIAL-PALMAR. CONTINUED ANTIBIOTIC THERAPY. NEXT CHECK-UP SCHEDULED FOR (B)(6) 2020. SURGICAL REVISION WITH REMOVAL OF MATERIAL AND RETOOLING.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10369302 ↗