Vital™ MIS Spinal Fixation System 850M6045Recalls & reported problems
Biomet Spine LLC · Class 2
All models of Vital MIS Spinal Fixation System (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868459030), received between Aug 29, 2022 and Aug 29, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2022Fracture; Fracture
IT WAS REPORTED WHILE INSERTING THE 5.5MM X 45MM SCREW AT T10 RIGHT SIDE WITHOUT TAPPING, THE SCREW BROKE. RIGHT AFTER THIS, BOTH 4.5MM TAPS BROKE WHEN DRILLING A PILOT HOLE ON THE RIGHT SIDE OF L2/L3 VERTEBRAL BODY. THE BROKEN SCREW REMAINS IMPLANTED WITHIN THE PATIENT BODY. THE TAPS WERE ABLE TO BE REMOVED USING EXTRA INSTRUMENTS. THE PATIENT HAS NEW LEG PAIN WHEN LYING DOWN AND SITTING POST-OPERATIVELY. THE PROCEDURE WAS DELAYED TWO HOURS DUE TO THE BREAKAGE, REMOVAL, AND RE-INSERTING THE SCREWS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: Pain
MAUDE report 15314857 ↗
Other Thoracolumbosacral pedicle screw system devices
- EXPEDIUM VERSE 199721000Medos International Sàrl · Orthosis, spinal pedicle fixation, for degenerative disc disease387 reports
- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- 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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