POLARIS™ 5.5 SPINAL SYSTEM 14-578540Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304942721), received between Jul 8, 2021 and Jul 8, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FIVE CLOSURE TOPS WOULD NOT MATE WITH THEIR MATING SCREW INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS WITHOUT PATIENT IMPACTS. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE CLOSURE TOP THREADS WERE STRIPPED. THIS IS REPORT THREE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139196 ↗
• MalfunctionJul 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FIVE CLOSURE TOPS WOULD NOT MATE WITH THEIR MATING SCREW INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS WITHOUT PATIENT IMPACTS. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE CLOSURE TOP THREADS WERE STRIPPED. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139181 ↗
• MalfunctionJul 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FIVE CLOSURE TOPS WOULD NOT MATE WITH THEIR MATING SCREW INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS WITHOUT PATIENT IMPACTS. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE CLOSURE TOP THREADS WERE STRIPPED. THIS IS REPORT TWO OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139176 ↗
• MalfunctionJul 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FIVE CLOSURE TOPS WOULD NOT MATE WITH THEIR MATING SCREW INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS WITHOUT PATIENT IMPACTS. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE CLOSURE TOP THREADS WERE STRIPPED. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139165 ↗
• MalfunctionJul 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT FIVE CLOSURE TOPS WOULD NOT MATE WITH THEIR MATING SCREW INTRA-OPERATIVELY. THEY WERE REMOVED AND REPLACED WITH OTHER CLOSURE TOPS WITHOUT PATIENT IMPACTS. HOWEVER, DEVICE EVALUATION BY THE MANUFACTURER FOUND THE CLOSURE TOP THREADS WERE STRIPPED. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139156 ↗