POLARIS 5.5 MULTIAXIAL SYS 14-592540Recalls & reported problems
Biomet Spine LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888480594277), received between Jul 27, 2020 and Jul 27, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Noise, Audible1
Patient problems
- Foreign Body In Patient1
- Inadequate Osseointegration1
- No Code Available1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2020Fracture; Noise, Audible; Fracture; Noise, Audible
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AFTER TWO POLARIS SCREWS WERE FOUND TO HAVE FRACTURED POSTOPERATIVELY AT S1. THE PATIENT REPORTED INCREASING BACK PAIN, LEFT LEG RADICULOPATHY AND A CREAKING SOUND FROM THE IMPLANTS PRIOR TO THE REVISION. THE FRACTURED PORTION OF THE SCREW WAS REMOVED BUT THE SHAFT WAS RETAINED BY THE PATIENT. THE LEVEL WAS REINSTRUMENTED AFTER THE SURGEON FOUND NO FUSION PRESENT. THE PATIENT REPORTS ONGOING BACK PAIN AFTER THE REVISION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: Foreign Body In Patient; Inadequate Osseointegration; No Code Available; Pain
MAUDE report 10330044 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- 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
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 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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