VITALITY® 701M6535Recalls & reported problems
Biomet Spine LLC · Class 2
All models of Vitality (38)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304867499), received between Oct 21, 2020 and Oct 21, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Biocompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Biocompatibility2
Patient problems
- Eczema2
- Hypersensitivity/Allergic reaction2
- Rash2
- Swelling2
- Swelling/ Edema2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2020Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE AN EPIC CONSTRUCT AND A BRECKENRIDGE CAGE. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT THREE OF 14 FOR THIS EVENT.
Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema
MAUDE report 10713180 ↗InjuryOct 21, 2020Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO SOME SPINAL IMPLANTS. THE INSTALLED IMPLANTS INCLUDE AN EPIC CONSTRUCT AND A BRECKENRIDGE CAGE. THE PATIENT IS ALLERGIC TO NICKEL AND MAY BE SENSITIVE TO COBALT CHROME. ALLERGY TESTS ARE ON-GOING AND A PLAN FOR CARE HAS NOT YET BEEN MADE. THIS IS REPORT FOUR OF 14 FOR THIS EVENT.
Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema
MAUDE report 10713155 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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