Virage OCT Spinal Fixation System 07.01707.013Recalls & reported problems
Highridge Medical, LLC · Polyaxial Smooth Shank Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03662663111751), received between Oct 30, 2025 and Oct 30, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Wrong Label” (3 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
- Wrong Label3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Wrong Label; Wrong Label
A DISTRIBUTOR REPORTED RECEIVING THREE 4.0X26 POLYAXIAL SMOOTH SHANK SCREWS IN PACKAGING LABELLED FOR 3.5X34 SCREWS. THIS WAS DISCOVERED PRIOR TO SURGICAL USE AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23426762 ↗MalfunctionOct 30, 2025Wrong Label; Wrong Label
A DISTRIBUTOR REPORTED RECEIVING THREE 4.0X26 POLYAXIAL SMOOTH SHANK SCREWS IN PACKAGING LABELLED FOR 3.5X34 SCREWS. THIS WAS DISCOVERED PRIOR TO SURGICAL USE AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23426754 ↗MalfunctionOct 30, 2025Wrong Label; Wrong Label
A DISTRIBUTOR REPORTED RECEIVING THREE 4.0X26 POLYAXIAL SMOOTH SHANK SCREWS IN PACKAGING LABELLED FOR 3.5X34 SCREWS. THIS WAS DISCOVERED PRIOR TO SURGICAL USE AND THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23426721 ↗
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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