Polaris 5.5 Spinal Fixation System 2000-9061Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03662663191876), received between Nov 12, 2025 and Aug 27, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Material Twisted/Bent

  It was reported that during the surgery, while inserting the closure tops using a Polaris plug driver, the closure tops were difficult to hold in place. The tip of the driver was determined to be twisted. There was no patient or procedural impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482082 ↗
• MalfunctionFeb 12, 2026Fracture

  IT WAS REPORTED THAT THE TIPS OF TWO POLARIS 5.5 PLUG DRIVERS BROKE OFF DURING FINAL TIGHTENING. THERE WERE NO IMPACTS TO THE PATIENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327957 ↗
• MalfunctionFeb 12, 2026Fracture

  IT WAS REPORTED THAT THE TIPS OF TWO POLARIS 5.5 PLUG DRIVERS BROKE OFF DURING FINAL TIGHTENING. THERE WERE NO IMPACTS TO THE PATIENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327932 ↗
• MalfunctionFeb 12, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF A POLARIS 5.5 PLUG DRIVER BROKE OFF INTRA-OP DURING FINAL TIGHTENING. THERE WERE NO IMPACTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327736 ↗
• MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO POLARIS 5.5 PLUG DRIVERS STRIPPED DURING A SURGERY. THERE WAS NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729614 ↗
• MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO POLARIS 5.5 PLUG DRIVERS STRIPPED DURING A SURGERY. THERE WAS NO PATIENT IMPACT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729600 ↗
• MalfunctionNov 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23547014 ↗
• MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS AND SEVEN POLARIS PLUG DRIVERS WITH DEFORMED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT FOUR OF NINE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23536161 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS AND SEVEN POLARIS PLUG DRIVERS WITH DEFORMED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT THREE OF NINE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23535656 ↗
• MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS AND SEVEN POLARIS PLUG DRIVERS WITH DEFORMED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT SEVEN OF NINE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23535487 ↗
• MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS AND SEVEN POLARIS PLUG DRIVERS WITH DEFORMED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT SIX OF NINE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23535440 ↗
• MalfunctionNov 12, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS AND SEVEN POLARIS PLUG DRIVERS WITH DEFORMED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT FIVE OF NINE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23535394 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT TWO POLARIS PLUG DRIVERS WITH FRACTURED TIPS AND SEVEN POLARIS PLUG DRIVERS WITH DEFORMED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED.THIS IS REPORT TWO OF NINE FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23534180 ↗