Vital Spinal Fixation System 07.02010.001Recalls & reported problems
Highridge Medical, LLC · Torque Set Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03662663117265), received between May 17, 2026 and Sep 30, 2026 — classified as 2 injuries, 3 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
- Migration2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that a revision surgery was scheduled for two set screws at the top of a Vital construct that were loose. Further patient impact information is unavailable.This is report three of four for this event.
Patient problems: Insufficient Information
MAUDE report 50950524 ↗InjurySep 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that a revision surgery was scheduled for two set screws at the top of a Vital construct that were loose. Further patient impact information is unavailable.This is report one of four for this event.
Patient problems: Insufficient Information
MAUDE report 50950083 ↗MalfunctionSep 28, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924799 ↗MalfunctionSep 28, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924527 ↗MalfunctionMay 17, 2026Material Deformation
IT WAS REPORTED THAT INTRA-OPERATIVELY, WHEN ATTEMPTING TO INSERT THE SET SCREW INTO THE RIGHT S1 PEDICLE SCREW, CROSS-THREADING OCCURRED. THE SCREW WAS UPSIZED AND REPLACED; HOWEVER, ALTHOUGH THE ROD AND SET SCREW WERE INSERTED, THE SCREW CAME OUT OF THE BONE. AS A RESULT, IT WAS DECIDED NOT TO FIX S1 AND NO SCREW WAS PLACED IN THE RIGHT S1. L3¿S1 FIXATION WAS PLANNED, HOWEVER FIXATION WAS COMPLETED FROM L3 TO L5. THERE WAS A 45 MINUTE DELAY BUT NO OTHER PATIENT IMPACT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196482 ↗
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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