POLARIS™ 5.5 SPINAL SYSTEM 14-500591Recalls & reported problems
Biomet Spine LLC · Class 2
All models of POLARIS 5.5 SPINAL SYSTEM (17)
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 00880304973701), received between Dec 11, 2024 and Dec 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Missing Information” (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
- Missing Information2
- Wrong Label2
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.
MalfunctionDec 11, 2024Missing Information; Wrong Label; Missing Information; Wrong Label
A HOSPITAL REPORTED THAT THEY RECEIVED TWO PACKAGES LABELLED FOR COBALT CHROME RODS BUT ACTUALLY CONTAINED TITANIUM RODS. ADDITIONALLY, THE REGULAR DEVICE LABEL WAS MISSING INFORMATION INCLUDING THE DESCRIPTION, MANUFACTURING DATE, AND CE MARKING. (ONLY ONE LABEL FOR THE PART NUMBER AND ANOTHER FOR THE LOT NUMBER). THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904663 ↗MalfunctionDec 11, 2024Missing Information; Wrong Label; Missing Information; Wrong Label
A HOSPITAL REPORTED THAT THEY RECEIVED TWO PACKAGES LABELLED FOR COBALT CHROME RODS BUT ACTUALLY CONTAINED TITANIUM RODS. ADDITIONALLY, THE REGULAR DEVICE LABEL WAS MISSING INFORMATION INCLUDING THE DESCRIPTION, MANUFACTURING DATE, AND CE MARKING. (ONLY ONE LABEL FOR THE PART NUMBER AND ANOTHER FOR THE LOT NUMBER). THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904607 ↗
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- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
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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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