Virage OCT Spinal Fixation System 07.01702.054Recalls & reported problems
Highridge Medical, LLC · Polyaxial Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663111492), received between May 7, 2026 and May 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device1
- Solder Joint Fracture1
Patient problems
- Difficulty Chewing1
- Dysphasia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Solder Joint Fracture; Malposition 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 ONE OF ELEVEN FOR THIS EVENT.
Patient problems: Difficulty Chewing; Dysphasia
MAUDE report 25117541 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page