Vital™ MIS Spinal Fixation System 824M6550Recalls & 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
- 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 00887868513848), received between Feb 26, 2025 and Feb 26, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth2
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.
MalfunctionFeb 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A SPINAL FUSION PATIENT WAS FOUND TO HAVE TWO CLOSURE TOPS AT L3 AND L5 THAT MIGRATED OUT OF THEIR MATING PEDICLE SCREWS. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY THREE WEEKS POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC AND IS CONSULTING WITH THEIR SURGEON TO DETERMINE IF A REVISION IS NECESSARY. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472981 ↗MalfunctionFeb 26, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A SPINAL FUSION PATIENT WAS FOUND TO HAVE TWO CLOSURE TOPS AT L3 AND L5 THAT MIGRATED OUT OF THEIR MATING PEDICLE SCREWS. THIS WAS DISCOVERED VIA X-RAY DURING A FOLLOW-UP APPOINTMENT APPROXIMATELY THREE WEEKS POST-OPERATIVELY. THE PATIENT IS ASYMPTOMATIC AND IS CONSULTING WITH THEIR SURGEON TO DETERMINE IF A REVISION IS NECESSARY. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472963 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page