Virage® 07.01728.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024328921), received between Apr 28, 2022 and Aug 22, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR VIRAGE CLOSURE TOPS BECAME DAMAGED AND CROSS-THREADED ON SCREWS INTRA-OPERATIVELY. THIS WAS CAUSED BY A KERRISON ROD REDUCER THAT HAD BECOME WORN, WITH A MALFORMED REDUCTION TIP. THERE WAS NO PATIENT IMPACT AND THE DAMAGED CLOSURE TOPS WERE DISCARDED. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874925 ↗
• MalfunctionAug 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR VIRAGE CLOSURE TOPS BECAME DAMAGED AND CROSS-THREADED ON SCREWS INTRA-OPERATIVELY. THIS WAS CAUSED BY A KERRISON ROD REDUCER THAT HAD BECOME WORN, WITH A MALFORMED REDUCTION TIP. THERE WAS NO PATIENT IMPACT AND THE DAMAGED CLOSURE TOPS WERE DISCARDED. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874896 ↗
• MalfunctionAug 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR VIRAGE CLOSURE TOPS BECAME DAMAGED AND CROSS-THREADED ON SCREWS INTRA-OPERATIVELY. THIS WAS CAUSED BY A KERRISON ROD REDUCER THAT HAD BECOME WORN, WITH A MALFORMED REDUCTION TIP. THERE WAS NO PATIENT IMPACT AND THE DAMAGED CLOSURE TOPS WERE DISCARDED. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874729 ↗
• MalfunctionAug 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR VIRAGE CLOSURE TOPS BECAME DAMAGED AND CROSS-THREADED ON SCREWS INTRA-OPERATIVELY. THIS WAS CAUSED BY A KERRISON ROD REDUCER THAT HAD BECOME WORN, WITH A MALFORMED REDUCTION TIP. THERE WAS NO PATIENT IMPACT AND THE DAMAGED CLOSURE TOPS WERE DISCARDED. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874721 ↗
• InjuryNov 20, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A VIRAGE CONSTRUCT FOR PSEUDOARTHROSIS. FURTHER INFORMATION REGARDING THE REVISION IS UNAVAILABLE AT THIS TIME. THIS IS REPORT SEVEN OF TEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20740934 ↗
• InjuryNov 20, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A VIRAGE CONSTRUCT FOR PSEUDOARTHROSIS. FURTHER INFORMATION REGARDING THE REVISION IS UNAVAILABLE AT THIS TIME. THIS IS REPORT EIGHT OF TEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20740862 ↗
• InjuryNov 20, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A VIRAGE CONSTRUCT FOR PSEUDOARTHROSIS. FURTHER INFORMATION REGARDING THE REVISION IS UNAVAILABLE AT THIS TIME. THIS IS REPORT SIX OF TEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20740499 ↗
• InjuryNov 20, 2024Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON A VIRAGE CONSTRUCT FOR PSEUDOARTHROSIS. FURTHER INFORMATION REGARDING THE REVISION IS UNAVAILABLE AT THIS TIME. THIS IS REPORT FIVE OF TEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20740381 ↗
• MalfunctionAug 7, 2024Material Deformation; Material Deformation

  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 ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934465 ↗
• InjuryApr 28, 2022Migration; Migration

  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 THREE OF THREE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 14246039 ↗