Virage OCT Spinal Fixation System 07.01728.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03662663112758), received between May 7, 2026 and May 7, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of Device” (4 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 18, 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.

• InjuryMay 7, 2026Malposition of Device

  IT WAS REPORTED THAT FOUR DAYS AFTER THE INITIAL SURGERY, A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TRISMUS AND DYSPHASIA. DURING REMOVAL, A COUPLE OF CLOSURE TOPS BECAME SEIZED AND THE ROD CONNECTOR WAS ALSO CUT OUT USING A HELICOIDAL RASP. A SCREW WAS ALSO FOUND TO HAVE FRACTURED AT THE WELD, AND WAS REMOVED AND REPLACED. THE PATIENT SYMPTOMS WERE ATTRIBUTED TO MALPOSITION OF THE DEVICES. THIS IS REPORT FIVE OF ELEVEN FOR THIS EVENT.

  Patient problems: Difficulty Chewing; Dysphasia

  MAUDE report 25117720 ↗
• InjuryMay 7, 2026Malposition of Device

  IT WAS REPORTED THAT FOUR DAYS AFTER THE INITIAL SURGERY, A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TRISMUS AND DYSPHASIA. DURING REMOVAL, A COUPLE OF CLOSURE TOPS BECAME SEIZED AND THE ROD CONNECTOR WAS ALSO CUT OUT USING A HELICOIDAL RASP. A SCREW WAS ALSO FOUND TO HAVE FRACTURED AT THE WELD, AND WAS REMOVED AND REPLACED. THE PATIENT SYMPTOMS WERE ATTRIBUTED TO MALPOSITION OF THE DEVICES. THIS IS REPORT FOUR OF ELEVEN FOR THIS EVENT.

  Patient problems: Difficulty Chewing; Dysphasia

  MAUDE report 25117667 ↗
• InjuryMay 7, 2026Malposition of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT FOUR DAYS AFTER THE INITIAL SURGERY, A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TRISMUS AND DYSPHASIA. DURING REMOVAL, A COUPLE OF CLOSURE TOPS BECAME SEIZED AND THE ROD CONNECTOR WAS ALSO CUT OUT USING A HELICOIDAL RASP. A SCREW WAS ALSO FOUND TO HAVE FRACTURED AT THE WELD, AND WAS REMOVED AND REPLACED. THE PATIENT SYMPTOMS WERE ATTRIBUTED TO MALPOSITION OF THE DEVICES. THIS IS REPORT THREE OF ELEVEN FOR THIS EVENT.

  Patient problems: Difficulty Chewing; Dysphasia

  MAUDE report 25117627 ↗
• InjuryMay 7, 2026Malposition of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT FOUR DAYS AFTER THE INITIAL SURGERY, A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TRISMUS AND DYSPHASIA. DURING REMOVAL, A COUPLE OF CLOSURE TOPS BECAME SEIZED AND THE ROD CONNECTOR WAS ALSO CUT OUT USING A HELICOIDAL RASP. A SCREW WAS ALSO FOUND TO HAVE FRACTURED AT THE WELD, AND WAS REMOVED AND REPLACED. THE PATIENT SYMPTOMS WERE ATTRIBUTED TO MALPOSITION OF THE DEVICES. THIS IS REPORT TWO OF ELEVEN FOR THIS EVENT.

  Patient problems: Difficulty Chewing; Dysphasia

  MAUDE report 25117596 ↗