Vitality® 07.02015.011Recalls & reported problems
Biomet Spine LLC · Class 2
All models of Vitality (38)
Data updated Oct 18, 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 00889024003996), 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 18, 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 TWO OF 14 FOR THIS EVENT.
Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema
MAUDE report 10713142 ↗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 ONE OF 14 FOR THIS EVENT.
Patient problems: Eczema; Hypersensitivity/Allergic reaction; Rash; Swelling; Swelling/ Edema
MAUDE report 10713112 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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