Vitality® 07.02030.003Recalls & 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 00889024007468), received between Jun 12, 2025 and Aug 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation
IT WAS REPORTED THAT HE CENTRAL SCREW SECTION OF THE ADJ CROSSLINK WAS DAMAGED. DURING THE FINAL TIGHTENING PROCESS, THE THREADS WERE STRIPPED, PREVENTING PROPER FASTENING, AND METAL FRAGMENTS WERE ALSO OBSERVED. THERE WAS NO PATIENT HARM OR PROCEDURAL IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22923246 ↗MalfunctionJun 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT AFTER REMOVING A VITALITY ADJUSTABLE TRANSVERSE CONNECTOR TO REPOSITION IT, THE SCREW ON ONE SIDE BECAME STUCK AND IT COULD NOT BE RE-INSTALLED. THE SAME SIZED VITALITY ADJUSTABLE TRANSVERSE CONNECTOR WAS USED TO COMPLETE THE PROCEDURE; THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22197059 ↗
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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