VirageRecalls & reported problems across all models
Zimmer Biomet Inc · 24 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 0
We found 24 models of Virage by Zimmer Biomet Inc in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2020 and Aug 27, 2026 — classified as 19 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Fracture” (38 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Virage problems
Device problems
- Fracture38
- Detachment of Device or Device Component5
- Material Deformation4
- Crack3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Mechanical Jam2
- Packaging Problem2
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Failure of Implant6
- Insufficient Information4
- Impaired Healing3
- Fall2
- Foreign Body In Patient2
- Pain2
- No Consequences Or Impact To Patient1
Virage models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Virage® 07.01702.007APPLIANCE, FIXATION, SPINAL INTERLAMINAL13 reports
- Virage® 07.01702.005APPLIANCE, FIXATION, SPINAL INTERLAMINAL6 reports
- Virage® 07.01764.002SCREWDRIVER5 reports
- Virage® 07.01702.009APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- Virage® 07.01702.015APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- Virage® 07.01702.062APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- Virage® 07.01702.023APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Virage® 07.01708.011APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Virage® 07.01708.012APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Virage® 07.01708.021APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Virage™ 07.01759.001PROBE1 report
- Virage™ 07.01805.001SCREWDRIVER1 report
- Virage® 07.01702.003APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01702.011APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01702.017APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01702.027APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01702.048APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01702.056APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01702.064APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01708.003APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01708.014APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01708.020APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01709.006APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Virage® 07.01727.001APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
Recent Virage adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionOct 29, 2025Crack; Crack
IT WAS REPORTED THAT FOLLOWING THE INSTALLATION OF A VIRAGE POLYAXIAL SCREW, FINAL TIGHTENING OF THE CLOSURE TOP CAUSED A CRACK IN THE UPPER PORTION ON ONE SIDE OF THE SCREW HEAD. THERE WAS A 60 MINUTE PROCEDURAL DELAY, BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415909 ↗MalfunctionSep 11, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING A HARDWARE REMOVAL SURGERY FOLLOWING A SUCCESSFUL FUSION, THE TIP OF A RIGID FINAL DRIVER BROKE OFF WHILE REMOVING THE RIGHT CLOSURE TOP OF THE OCCIPITAL PLATE. IT WAS CONFIRMED THAT NO REMNANTS WERE LEFT INSIDE THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23032310 ↗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 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO VIRAGE DRIVER TIPS FRACTURED WHEN ATTEMPTING TO REMOVE A SCREW AT T-2 INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED WITH A THIRD DRIVER, RESULTING IN A 20 MINUTE DELAY BUT NO PATIENT HARM. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22100068 ↗MalfunctionMay 28, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO VIRAGE DRIVER TIPS FRACTURED WHEN ATTEMPTING TO REMOVE A SCREW AT T-2 INTRA-OPERATIVELY. THE SURGERY WAS COMPLETED WITH A THIRD DRIVER, RESULTING IN A 20 MINUTE DELAY BUT NO PATIENT HARM. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22100058 ↗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 ↗InjuryMar 7, 2025Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A PATIENT¿S CONSTRUCT THAT BROKE DOWN AT T2 AND C4 (THE ROD WAS NOT SECURED ON THE SCREW SHANKS). DURING THE SURGERY, THE SURGEON NOTICED THAT THE TULIP HEADS OF TWO VIRAGE SCREWS POPPED OFF.THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551863 ↗InjuryMar 7, 2025Fracture; Fracture
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A PATIENT¿S CONSTRUCT THAT BROKE DOWN AT T2 AND C4 (THE ROD WAS NOT SECURED ON THE SCREW SHANKS). DURING THE SURGERY, THE SURGEON NOTICED THAT THE TULIP HEADS OF TWO VIRAGE SCREWS POPPED OFF. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551859 ↗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 ONE OF TWO FOR THIS EVENT.
Patient problems: Pain
MAUDE report 21333602 ↗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 ↗MalfunctionJan 7, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TULIP HEAD OF A VIRAGE SCREW WAS DISCOVERED TO BE BROKEN AT THE WELD POST-OPERATIVELY DURING A SIX MONTH FOLLOW-UP VISIT. THE SCREW WAS NOT EXPLANTED AS THE PATIENT IS CURRENTLY ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095993 ↗MalfunctionJan 7, 2025Fracture; Fracture
IT WAS REPORTED THAT A VIRAGE TULIP BROKE OFF THE SHANK OF THE SCREW AT C1 AS THE SURGEON WAS OPERATING. THEY WERE ABLE TO RETRIEVE THE SCREW AND REVISE TO A LARGER DIAMETER SCREW. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 20 MINUTE DELAY WHILE THE SCREW WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21095972 ↗MalfunctionOct 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, A VIRAGE SCREWDRIVER FRACTURED AT THE TIP AND A 5.5MM DIAMETER VIRAGE SCREW BROKE APART AT THE TULIP HEAD. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL SCREW DRIVERS AND SCREWS IN THEIR SET. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10-15 MINUTE DELAY TO GRAB NEW SCREW DRIVERS AND SCREW. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452819 ↗MalfunctionOct 15, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, A VIRAGE SCREWDRIVER FRACTURED AT THE TIP AND A 5.5MM DIAMETER VIRAGE SCREW BROKE APART AT THE TULIP HEAD. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL SCREW DRIVERS AND SCREWS IN THEIR SET. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10-15 MINUTE DELAY TO GRAB NEW SCREW DRIVERS AND SCREW.THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20452810 ↗
Other Zimmer Biomet Inc products
All Zimmer Biomet Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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