Vitality® 07.02050.166Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024009592), received between May 24, 2021 and Nov 3, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
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.
MalfunctionNov 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT AN ILIAC SCREW DISASSEMBLED DURING INSTALLATION INTRA-OPERATIVELY. THE SCREW'S SHAFT WAS REMOVED AND REPLACED WITH ANOTHER ILIAC SCREW WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12748506 ↗MalfunctionMay 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ILIAC TULIP DISENGAGED WITH THE SCREW SHANK WITH LITTLE TO NO PRESSURE. THE SURGEON WAS USING THE SCREW HEAD TURNER AND THE TULIP POPPED OFF. THE SCREW WAS REMOVED AND REPLACED WITH A DIFFERENT ILIAC SCREW. THERE WAS NO REPORTED IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11869850 ↗
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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