Solstice Occipito-Cervico-Thoracic System 9435-12Recalls & reported problems
Life Spine, Inc. · SOLSTICE Polyaxial Screw Assembly 3.5mm x 12mm · Class 2
Data updated Oct 16, 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 00190837024673), received between May 15, 2025 and May 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Inaccurate Information; Inaccurate Information
IT WAS STATED THAT "ONE OF THE (9435-12) 3.5 X 12 SOLSTICE RESTOCK SCREWS WAS INCORRECTLY SIZED AND LABELED. IT WAS LABELED A 3.5 X 12MM SCREW ON THE ACTUAL SCREW AND PACKAGING BUT I NOTICED IT LOOKED A LITTLE TOO LONG TO BE A 12MM SCREW. WHEN I MEASURED IT ON THE CADDY YOU CAN SEE THE SCREW IS ACTUALLY A 14MM SCREW LENGTH. ONE OF THE TOWERS FROM THE SOLSTICE SYSTEM IS STUCK IN ITS FULLY COMPRESSED POSITION AND CAN NOT BE BACKED OUT BECAUSE IT IS JAMMED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029827 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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