Polaris 5.5 Spinal Fixation SystemRecalls & reported problems across all models
Highridge Medical, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 8 models of Polaris 5.5 Spinal Fixation System by Highridge Medical, LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Nov 12, 2025 and Aug 27, 2026 — classified as 3 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Polaris 5.5 Spinal Fixation System problems
Device problems
- Fracture12
- Material Twisted/Bent8
- Material Deformation3
- Mechanical Problem1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions7
- Foreign Body In Patient3
Polaris 5.5 Spinal Fixation System models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Polaris 5.5 Spinal Fixation System 2000-9061SCREWDRIVER13 reports
- Polaris 5.5 Spinal Fixation System 14-501680Orthopedic manual surgical instrument3 reports
- Polaris 5.5 Spinal Fixation System 14-500360Orthopedic manual surgical instrument2 reports
- Polaris 5.5 Spinal Fixation System 14-501700SCREWDRIVER1 report
- Polaris 5.5 Spinal Fixation System 14-501732SCREWDRIVER1 report
- Polaris 5.5 Spinal Fixation System 14-501801Orthopedic manual surgical instrument1 report
- Polaris 5.5 Spinal Fixation System 2000-9072Orthopedic manual surgical instrument1 report
- 1 report
Recent Polaris 5.5 Spinal Fixation System adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionJun 4, 2026Fracture; Material Twisted/Bent
IT WAS REPORTED THAT THE TIP OF A FINAL DRIVER TWISTED AND FRACTURED OFF INTRA-OPERATIVELY. THE SURGEON IMPROVISED DURING THE PROCEDURE, BUT THERE WERE NO PATIENT IMPACTS SINCE THERE WAS A BACKUP PLUG DRIVER AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393808 ↗MalfunctionMay 17, 2026Mechanical Problem
IT WAS REPORTED THAT DURING INSPECTION OF A FIELD RETURN FROM A HOSPITAL, A WAREHOUSE DISCOVERED A DEFECTIVE POLARIS DORSAL HEIGHT ADJUSTER. THE HOSPITAL DID NOT PROVIDE ANY PATIENT OR EVENT INFORMATION. UPON MANUFACTURER INVESTIGATION, IT WAS FOUND THAT THE DRIVER TIP WAS FRACTURED.
Patient problems: Insufficient Information
MAUDE report 25196485 ↗InjuryMay 12, 2026Fracture
IT WAS REPORTED THAT DURING A REVISION SURGERY, A 2.5MM REMOVAL HEX BIT FRACTURED. THE SCREW WAS UNABLE TO BE REMOVED AND THE TIP REMAINS IMPLANTED.
Patient problems: Foreign Body In Patient
MAUDE report 25151488 ↗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 ↗MalfunctionJan 12, 2026Fracture
IT WAS REPORTED THAT THREE TL REMOVAL HEXALOBE BITS WITH FRACTURED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 24046287 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREE CYPHER DORSAL HEIGHT ADJUSTERS WITH DAMAGED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23843956 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREE CYPHER DORSAL HEIGHT ADJUSTERS WITH DAMAGED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT, SURGICAL, AND EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23843936 ↗MalfunctionDec 18, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THREE CYPHER DORSAL HEIGHT ADJUSTERS WITH DAMAGED TIPS WERE DISCOVERED AT A WAREHOUSE UPON RETURN FROM THE FIELD. PATIENT/SURGICAL/EVENT INFORMATION WAS NOT PROVIDED. THIS IS REPORT ONE OF THREE FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 23843804 ↗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 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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