Virage® 07.01708.011Recalls & 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
- 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 00889024328280), received between Nov 12, 2020 and Jul 17, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Deformation1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TULIP HEAD OF A VIRAGE POLYAXIAL SCREW COMPLETELY FRACTURED FROM THE SHANK OF THE SCREW INTRA-OPERATIVELY. THE SCREW SHAFT WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT SO IT WAS LEFT; THERE WAS A DELAY OF 10-15 MINUTES WHILE TRYING TO RETRIEVE THE BROKEN PART OF THE SCREW.
Patient problems: Foreign Body In Patient
MAUDE report 22535015 ↗MalfunctionNov 12, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE FIRST THREAD OF THE TULIP ON A POLYAXIAL SCREW STRIPPED WHILE THE SURGEON WAS INSTALLING THE CLOSURE TOP INTO PLACE. THE SCREW WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10830241 ↗
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- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
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- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
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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.
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