Virage® 07.01702.007Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024327009), received between Dec 14, 2021 and Aug 7, 2024 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT A VIRAGE SET SCREW WOULD NOT SEAT IN IT'S MATING SCREW, RESULTING IN STRIPPED THREADS. ADDITIONALLY, THE SCREW TULIP HEAD SHEARED OFF. THE DEVICES WERE REMOVED AND REPLACED AND THERE WAS NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934476 ↗
• MalfunctionJul 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER FINAL TIGHTENING, THE VIRAGE CONSTRUCT WAS INSPECTED AND TWO VIRAGE SCREWS WERE FOUND TO HAVE FRACTURED. THEY WERE REPLACED WITH SCREWS OF A LARGER DIAMETER AND THE SURGERY WAS COMPLETED WITHOUT PATIENT HARM, ALTHOUGH THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19866854 ↗
• MalfunctionJul 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER FINAL TIGHTENING, THE VIRAGE CONSTRUCT WAS INSPECTED AND TWO VIRAGE SCREWS WERE FOUND TO HAVE FRACTURED. THEY WERE REPLACED WITH SCREWS OF A LARGER DIAMETER AND THE SURGERY WAS COMPLETED WITHOUT PATIENT HARM, ALTHOUGH THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19866826 ↗
• MalfunctionJul 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TULIP HEAD OF VIRAGE OCT POLYAXIAL SCREW BROKE OFF INTRA-OPERATIVELY. THE DOCTOR REMOVED IT AND REPLACED IT WITH ANOTHER 3.5X14 POLYAXIAL SCREW. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776937 ↗
• MalfunctionNov 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT A VIRAGE SCREW FRACTURE WAS DISCOVERED BY POSTOPERATIVE CT SCAN AND CONFIRMED BY X-RAY THAT MAY HAVE OCCURRED DURING THE FINAL CLOSURE OF THE SURGERY, ALTHOUGH THIS IS NOT CERTAIN. A REVISION SURGERY WAS NOT PERFORMED, AND THE PATIENT IS BEING TREATED WITH A HALO VEST. THE PATIENT IS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162831 ↗
• MalfunctionOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF A VIRAGE SCREW AT LEFT C5, THE HOUSING BASE BROKE. THE SCREW WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS A 15-MINUTE DELAY AND NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967008 ↗
• MalfunctionJun 7, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A VIRAGE 3.5X20MM SCREW WAS PACKAGED AS A 3.5X14MM SCREW. THERE WAS NO REPORTED PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082537 ↗
• MalfunctionMay 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE LOWER HOUSING ON A VIRAGE SCREW FRACTURED INTRA-OPERATIVELY. THE SCREW WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904598 ↗
• MalfunctionOct 7, 2022Crack; Crack

  IT WAS REPORTED THAT TWO VIRAGE SCREWS BROKE AT THE WELD AND THREE OTHERS CRACKED AT THE WELD INTRA-OPERATIVELY. ON ONE SCREW, THE SURGEON PUSHED ON IT FROM ABOVE AFTER THE CLOSURE TOP WAS TIGHTENED AND THE LOWER HOUSING BROKE INTO TWO PIECES AT THE WELDS. THEN THE SURGEON NOTICED THE OTHER FOUR SCREWS THAT EITHER BROKE OR CRACKED. ALL OF THE SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566469 ↗
• InjuryApr 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT FELL AND A SUBSEQUENT X-RAY FOUND THAT TWO VIRAGE SCREWS WERE BROKEN. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SCREWS WITH 0.5MM LARGER DIAMETER VIRAGE SCREWS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Fall

  MAUDE report 14246571 ↗
• InjuryApr 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT FELL AND A SUBSEQUENT X-RAY FOUND THAT TWO VIRAGE SCREWS WERE BROKEN. A REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE SCREWS WITH 0.5MM LARGER DIAMETER VIRAGE SCREWS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: Fall

  MAUDE report 14246484 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO SCREWS BROKE APART AFTER BEING FINAL TIGHTENED INTRA-OPERATIVELY. THEY SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003953 ↗
• MalfunctionDec 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT TWO SCREWS BROKE APART AFTER BEING FINAL TIGHTENED INTRA-OPERATIVELY. THEY SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003952 ↗