Solstice Occipito-Cervico-Thoracic System 2014-0009Recalls & reported problems
Life Spine, Inc. · Solstice Drill/Tap 2.25mm/ 3.5mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190837040215), received between Jul 2, 2025 and Apr 14, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Fracture
IT WAS STATED THAT, "THE DRILL/TAP BROKE GOING INTO THE RIGHT C2 PEDICLE. THE DISTAL PORTION OF SAID TAP WAS REMOVED WITH A NEEDLE DRIVER. I AM NOT AWARE OF ANY ISSUES CONCERNING THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874728 ↗MalfunctionJan 20, 2026Fracture
IT WAS STATED THAT " DRILL BROKE WHILE INSERTING INTO THE RIGHT C2 PEDICLE, WAS REMOVED. TO MY KNOWLEDGE THERE WERE NO OTHER ISSUES. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115755 ↗MalfunctionJul 2, 2025Fracture; Fracture
IT WAS STATED THAT, "IN THE CASE YESTERDAY, [THE DOCTOR] HAD THE TAP SNAP WHILE TAPPING LEFT C2."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22382417 ↗
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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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