Virage® 07.01702.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024327023), received between Apr 28, 2022 and Jul 24, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJul 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT A VIRAGE 3.5X16 MM SCREW BROKE DURING FINAL TIGHTENING. THE THE BOTTOM HALF OF THE SCREW'S TULIP BROKE INTO PIECES, ALLOWING THE UPPER PORTION OF THE TULIP TO DETACH FROM THE SCREW SHAFT. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHAFT AND REPLACE IT WITH A NEW SCREW. THERE WERE NO IMPACTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17385517 ↗
• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HOUSING THREADS ON TWO VIRAGE SCREWS WERE DAMAGED WHILE THE CLOSURE TOPS WERE BEING INSTALLED INTO THEM INTRA-OPERATIVELY. BOTH SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY, BUT WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463208 ↗
• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HOUSING THREADS ON TWO VIRAGE SCREWS WERE DAMAGED WHILE THE CLOSURE TOPS WERE BEING INSTALLED INTO THEM INTRAOPERATIVELY. BOTH SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY, BUT WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14463169 ↗
• InjuryApr 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A VIRAGE CLOSURE TOP MIGRATED OUT OF THE SCREW, ALLOWING THE ROD TO MOVE POST-OPERATIVELY. THIS WAS DISCOVERED VIA X-RAY AT THE THREE WEEK FOLLOW-UP AND A REVISION SURGERY WAS PERFORMED THE NEXT DAY TO REMOVE AND REPLACE THE SCREW, ROD, AND CLOSURE TOP. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14246115 ↗