Polaris 5.5 Spinal Fixation System 14-501680Recalls & reported problems
Highridge Medical, LLC · DORSAL HEIGHT ADJUSTER · Class 1
All models of Polaris 5.5 Spinal Fixation System (8)
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 03662663135931), received between Dec 18, 2025 and Dec 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREE CYPHER DORSAL HEIGHT ADJUSTERS WITH DAMAGED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23843956 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREE CYPHER DORSAL HEIGHT ADJUSTERS WITH DAMAGED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT, SURGICAL, AND EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23843936 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREE CYPHER DORSAL HEIGHT ADJUSTERS WITH DAMAGED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23843804 ↗
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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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