Vital™ MIS Spinal Fixation System 850M0078Recalls & reported problems
Biomet Spine LLC · Class 1
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 00887868455674), received between Jul 10, 2024 and Jul 9, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Deformation1
- Material Twisted/Bent1
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.
MalfunctionJul 9, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING INSPECTION, IT WAS DISCOVERED THAT THE TIP OF THE VITAL T27 DRIVER WAS DAMAGED AND THAT IT WOULD NO LONGER HOLD THE CAPS. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460370 ↗MalfunctionJul 10, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT TWO VITALITY CANNULATED DRIVERS AND A VITALITY T27 CLOSURE TOP INSERTER FRACTURED INTRA-OPERATIVELY WHILE DRIVING A SCREW, BUT THAT THESE FRACTURES RESULTED IN NO PROCEDURAL DELAYS OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT THE TIPS HAD BECOME TWISTED AND COMPROMISED OVER USE AND TIME. NO ADDITIONAL INSTRUMENTATION WAS REQUIRED TO COMPLETE THE SURGERY AND ALL PIECES WERE REMOVED PRIOR TO ROD INSERTION.THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19716084 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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