POLARIS 5.5 SPINE SYSTEM 2000-1005Recalls & reported problems
Biomet Spine LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888480207115), received between Dec 20, 2021 and Dec 20, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (5 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.
Most reported problems
Device problems
- Material Deformation5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2021Material Deformation; Material Deformation
IT WAS REPORTED FIVE POLARIS PLUGS STRIPPED INTRAOPERATIVELY. THEY WERE REMOVED AND REPLACED WITHOUT PATIENT IMPACTS. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046037 ↗MalfunctionDec 20, 2021Material Deformation; Material Deformation
IT WAS REPORTED FIVE POLARIS PLUGS STRIPPED INTRAOPERATIVELY. THEY WERE REMOVED AND REPLACED WITHOUT PATIENT IMPACTS. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046023 ↗MalfunctionDec 20, 2021Material Deformation; Material Deformation
IT WAS REPORTED FIVE POLARIS PLUGS STRIPPED INTRAOPERATIVELY. THEY WERE REMOVED AND REPLACED WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13045919 ↗MalfunctionDec 20, 2021Material Deformation; Material Deformation
IT WAS REPORTED FIVE POLARIS PLUGS STRIPPED INTRAOPERATIVELY. THEY WERE REMOVED AND REPLACED WITHOUT PATIENT IMPACTS. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13045901 ↗MalfunctionDec 20, 2021Material Deformation; Material Deformation
IT WAS REPORTED FIVE POLARIS PLUGS STRIPPED INTRAOPERATIVELY. THEY WERE REMOVED AND REPLACED WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13045812 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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