Virage® 07.01702.062Recalls & reported problems
Zimmer Biomet Inc · Class 2
- 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 00889024327559), received between Jun 21, 2024 and Aug 27, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Deformation1
- Noise, Audible1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Material Deformation; Noise, Audible
It was reported that during posterior fixation from C3 to T3, the screws were implanted and the rod was seated. While attempting to provisionally tighten the set screw, an abnormal noise was heard from the left C7 screw and the set screw could not be properly seated. The screw was removed and inspected, revealing that a portion of the internal threading of the tulip head was deformed. The screw was therefore determined to be unusable and was discarded. The affected screw was replaced with a new one, and the procedure was completed without any further issues. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50483776 ↗InjuryFeb 7, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO VIRAGE SCREWS AT THE END OF A CONSTRUCT WERE DISCOVERED TO BE FRACTURED ON POST-OP IMAGES. IT WAS REPORTED THAT THE PATIENT SNEEZED AND FELT PAIN AT HOME. A REVISION SURGERY IS PLANNED BUT HAS NOT YET BEEN SCHEDULED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Pain
MAUDE report 21333517 ↗InjuryJun 21, 2024Fracture; Fracture
IT WAS REPORTED THAT A THE TULIP OF A VIRAGE SCREW WAS FOUND TO HAVE FRACTURED POST-OPERATIVELY. A REVISION WAS SUBSEQUENTLY PERFORMED TO REMOVE AND REPLACE THE SCREW WITH COMPETITIVE PRODUCT.
Patient problems: Failure of Implant
MAUDE report 19589041 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.