Vitality® 07.02015.008Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024003965), received between Dec 20, 2019 and Dec 20, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
- Packaging Problem1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT A HOSPITAL RECEIVED THE INCORRECT PRODUCT IN TWO PACKAGES. THE PACKAGES CONTAINED 50MM RODS INSTEAD OF THE LABELED 55MM RODS. THE PRODUCT WAS DISCOVERED BY THE HOSPITAL COMPLAINANT AND THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT ONE OF TWO.
Patient problems: No Patient Involvement
MAUDE report 9501511 ↗MalfunctionDec 20, 2019Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A HOSPITAL RECEIVED THE INCORRECT PRODUCT IN TWO PACKAGES. THE PACKAGES CONTAINED 50MM RODS INSTEAD OF THE LABELED 55MM RODS. THE PRODUCT WAS DISCOVERED BY THE HOSPITAL COMPLAINANT AND THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT TWO OF TWO.
Patient problems: No Patient Involvement
MAUDE report 9501496 ↗
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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