POLARIS™ 5.5 SPINAL SYSTEM 2000-2445Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304925182), received between Apr 16, 2021 and Jul 19, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth2
- Crack1
- Mechanical Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Spinal Column Injury2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE TWO POLARIS 5.5 MULTIAXIAL SCREWS DUE TO THEIR BEING LOOSE AND SPONDYLOSIS. THE SCREWS WERE REPLACED BY SCREWS THE NEXT SIZE UP. THE REVISION WAS SUCCESSFUL AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: Spinal Column Injury
MAUDE report 19783092 ↗InjuryJul 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REPLACE TWO POLARIS 5.5 MULTIAXIAL SCREWS DUE TO THEIR BEING LOOSE AND SPONDYLOSIS. THE SCREWS WERE REPLACED BY SCREWS THE NEXT SIZE UP. THE REVISION WAS SUCCESSFUL AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Spinal Column Injury
MAUDE report 19783070 ↗MalfunctionJun 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT AS A MULTIAXIAL SCREW WAS INSERTED INTO THE PATIENT THERE WAS PHYSICAL RESISTANCE. THE SURGEON USED A NEW SCREW OF THE SAME PART NUMBER TO COMPLETE THE CASE. THERE WAS NO REPORTED DELAY OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12032081 ↗MalfunctionApr 16, 2021Crack; Mechanical Problem
IT WAS REPORTED THE POLARIS SCREW WAS FOUND TO HAVE A CRACK AT THE END OF THE SCREW CONNECTION DURING THE OPERATION. ANOTHER SCREW WAS USED TO COMPLETE THE OPERATION. NO PATIENT IMPACT WAS REPORTED. HOWEVER, UPON DEVICE EVALUATION BY THE MANUFACTURER, THE SCREW WAS FOUND TO HAVE LOST ITS POLYAXIAL MOTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11680443 ↗
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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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