Polaris 5.5 Spinal Fixation System 14-500360Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663133630), received between Dec 18, 2025 and Jul 10, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Fracture

  IT WAS REPORTED THAT WHEN TRYING TO REMOVE A K-WIRE FROM THE PATIENT AFTER INSERTING VITAL MIS SCREWS INTRA-OPERATIVELY, THE TIP OF THE WIRE FRACTURED OFF. THE TIP REMAINS EMBEDDED IN THE VERTEBRAL BODY BUT THE PATIENT IS ASYMPTOMATIC AND THERE WAS NO OTHER PATIENT OR PROCEDURAL IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25786082 ↗
• InjuryDec 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A POLARIS 5.5 K-WIRE BROKE OFF INTO THE PATIENT DURING A POSTERIOR FUSION; THE TIP WAS RETAINED. FURTHER INFORMATION ABOUT PATIENT IMPACT IS UNKNOWN AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 23839653 ↗