Virage® 07.01702.015Recalls & reported problems
Zimmer Biomet Inc · Class 2
All models of Virage (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024327085), received between Dec 20, 2023 and Mar 18, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A 4-MONTH POST-OPERATION CHECK-UP, A VIRAGE SCREW WITH A FRACTURED TULIP HEAD AT THE WELDS WAS FOUND VIA X-RAY. THE PATIENT IS CURRENTLY EXPERIENCING NO SYMPTOMS AND A REVISION SURGERY IS NOT PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21638844 ↗InjuryDec 20, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN X-RAY APPROXIMATELY 1 WEEK POSTOPERATIVELY, THE C7 LEFT SCREW SHOWED A CRACK, AND AN X-RAY APPROXIMATELY 2 MONTHS POST-OPERATIVELY SHOWED THAT THE TULIP HEAD FRACTURED ON TWO SCREWS. A REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT AND REPLACE IT WITH COMPETITIVE PRODUCT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Failure of Implant
MAUDE report 18367649 ↗InjuryDec 20, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING AN X-RAY APPROXIMATELY 1 WEEK POSTOPERATIVELY, THE C7 LEFT SCREW SHOWED A CRACK, AND AN X-RAY APPROXIMATELY 2 MONTHS POST-OPERATIVELY SHOWED THAT THE TULIP HEAD FRACTURED ON TWO SCREWS. A REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT AND REPLACE IT WITH COMPETITIVE PRODUCT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Failure of Implant
MAUDE report 18367596 ↗
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
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · 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 16, 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