POLARIS 5.5 SPINAL SYSTEM 2000-2450Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888480207764), received between Sep 13, 2021 and Dec 22, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.
Most reported problems
Device problems
- Physical Resistance/Sticking2
- Material Twisted/Bent1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING SURGERY, THREE MULTI-AXIAL SCREW HEADS JAMMED SO THEY LOST THEIR POLYAXIAL MOTION. NEW SCREWS WERE USED TO COMPLETE THE CASE WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13062900 ↗MalfunctionDec 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED A POLYAXIAL SCREW LOT ITS POLYAXIAL MOTION INTRA-OPERATIVELY. IT WAS REMOVED AND REPLACED WITH ANOTHER SCREW TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13046192 ↗InjurySep 13, 2021Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem
IT WAS REPORTED A REVISION WAS PERFORMED TO REMOVE A PEDICLE SCREW BECAUSE A SCAN SHOWED THE SCREW HAD BREACHED THE PEDICLE WALL. WHEN THE SCREW WAS REMOVED, THE SHAFT OF THE SCREW WAS VERY SLIGHTLY BENT. A NEW SCREW WAS PLACED DURING THE REVISION.
Patient problems: Pain
MAUDE report 12463837 ↗
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- EXPEDIUM 179712650Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation31 reports
- EXPEDIUM VERSE 199721530Medos International Sàrl · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4 5 48130000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation29 reports
- XIA 4.5 System - XIA CT 48850000Stryker Corporation · Orthosis, spondylolisthesis spinal fixation27 reports
- CD HORIZON® Spinal System 7576545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation26 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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