Virage® OCT 300P0010Recalls & reported problems
Highridge Medical, LLC · Open-Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm) · Class 2 · Implant
Data updated Oct 13, 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 03662663079846), received between May 7, 2026 and May 7, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Malposition of Device1
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, 2026Difficult to Remove; 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 ELEVEN OF ELEVEN FOR THIS EVENT.
Patient problems: Difficulty Chewing; Dysphasia
MAUDE report 25117881 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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