Virage® 07.01702.005Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024326989), received between Oct 7, 2022 and Aug 22, 2024 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component3
- Crack1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Mechanical Jam1
Patient problems
- Failure of Implant3
- Impaired Healing3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE A LOOSENING VIRAGE OCT SCREW; THE PATIENT HAS BAD BONE. PATIENT IMPACT BEYOND THE REVISION SURGERY IS CURRENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20024323 ↗InjuryDec 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TULIP HEADS OF THREE VIRAGE SCREWS DISASSEMBLED POST-OPERATIVELY, RESULTING IN THE PATIENT NEEDING A HARD COLLAR BRACE. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 18303536 ↗InjuryNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TULIP HEADS OF TWO VIRAGE SCREWS DISASSEMBLED POST-OPERATIVELY, RESULTING IN THE PATIENT NEEDING A HARD COLLAR BRACE. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 18232522 ↗InjuryNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TULIP HEADS OF TWO VIRAGE SCREWS DISASSEMBLED POST-OPERATIVELY, RESULTING IN THE PATIENT NEEDING A HARD COLLAR BRACE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 18232416 ↗MalfunctionJul 25, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT A SCREW WOULD NOT RELEASE FROM THE DRIVER INTRA-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17391381 ↗MalfunctionOct 7, 2022Crack; Crack
IT WAS REPORTED THAT TWO VIRAGE SCREWS BROKE AT THE WELD AND THREE OTHERS CRACKED AT THE WELD INTRA-OPERATIVELY. ON ONE SCREW, THE SURGEON PUSHED ON IT FROM ABOVE AFTER THE CLOSURE TOP WAS TIGHTENED AND THE LOWER HOUSING BROKE INTO TWO PIECES AT THE WELDS. THEN THE SURGEON NOTICED THE OTHER FOUR SCREWS THAT EITHER BROKE OR CRACKED. ALL OF THE SCREWS WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15568304 ↗
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