Virage OCT Spinal Fixation System 07.01721.003Recalls & reported problems
Highridge Medical, LLC · Transverse Connector, Rod to Rod · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663112673), received between Dec 18, 2025 and Dec 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN THE TRANSVERSE CONNECTOR WAS INSERTED INTO THE BODY, THE LEFT SIDE ENGAGED PROPERLY WITH THE ROD, BUT THE RIGHT SIDE DID NOT ENGAGE CORRECTLY. AS A RESULT, THE CONNECTOR WAS REMOVED AND NOT USED. INTRAOPERATIVELY, IT WAS CONFIRMED FROM A DISTANCE THAT THE CONNECTOR HAD SUFFICIENT ENGAGEMENT RANGE, AND THERE WAS NO APPARENT CONTACT WITH THE BONE OR OTHER STRUCTURES. BOTH CLAMPS WERE LOOSENED AND HANDED TO THE SURGEON. SINCE THE RIGHT SIDE WOULD NOT ENGAGE, THE SURGEON LOOSENED IT SLIGHTLY FURTHER. ALTHOUGH ATTEMPTS WERE MADE TO PUSH IN THE RIGHT SIDE, APPLYING EXCESSIVE FORCE COULD HAVE CAUSED CERVICAL SPINE INJURY. AFTER SEVERAL ATTEMPTS, THE PROCEDURE WAS COMPLETED AS PLANNED, BUT WITHOUT IMPLANTING THE TRANSVERSE CONNECTOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23842575 ↗
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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