Virage OCT Spinal Fixation System 07.01708.012Recalls & reported problems
Highridge Medical, LLC · Polyaxial Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663112123), received between Dec 23, 2025 and Jul 7, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2026Fracture
IT WAS REPORTED THAT A VIRAGE SCREW FRACTURED UNDERNEATH THE TULIP DURING AN OTHERWISE STRAIGHTFORWARD C2-T2 SURGERY. THIS RESULTED IN A ONE HOUR DELAY, AND THE SCREW SHANK WAS LEFT IN THE PATIENT AT RIGHT T1. THERE WAS NO FURTHER REPORTED PATIENT IMPACT.
Patient problems: Foreign Body In Patient
MAUDE report 25735258 ↗MalfunctionDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A VIRAGE OPEN CONNECTOR COULD NOT BE INSERTED BETWEEN C7 AND T1 INTRAOPERATIVELY BECAUSE OF INTERFERENCE WITH THE INFERIOR FACET JOINTS AND LAMINA LOCATED BENEATH THE ROD. THE SURGEON REMOVED THE SCREW AT T1 TO ALLOW FOR MORE ROOM FOR THE OPEN CONNECTOR. HOWEVER, THE HEAD OF THE SCREW FRACTURED DURING REMOVAL. THERE WAS A FIVE MINUTE DELAY TO REMOVE THE SCREW AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879883 ↗
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.
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