POLARIS™ 5.5 SPINAL SYSTEM 2000-2335Recalls & reported problems
Biomet Spine LLC · Class 2
All models of POLARIS 5.5 SPINAL SYSTEM (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304925373), received between Jul 11, 2023 and Aug 16, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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
Device problems
- Manufacturing, Packaging or Shipping Problem2
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT TWO POLARIS SCREW PACKAGES CONTAINED THE INCORRECT SIZE SCREWS. THEY WERE FOUND UPON RECEIPT SO THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17556961 ↗MalfunctionAug 16, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT TWO POLARIS SCREW PACKAGES CONTAINED THE INCORRECT SIZE SCREWS. THEY WERE FOUND UPON RECEIPT SO THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT ONE OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17556937 ↗MalfunctionJul 11, 2023Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT TWO SCREWS WERE RECEIVED THAT WERE LASER MARKED AS PART NUMBER 2000-2435, BUT THE LABELS STATED THE SCREWS WERE PART NUMBER 2000-2345. THERE WAS NO PATIENT PRESENT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300385 ↗
Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices
- EXPEDIUM 179702000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL439 reports
- EXPEDIUM VERSE 199721001Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL227 reports
- XIA 3 48230000Stryker Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL193 reports
- VIPER 186715000Medos International Sàrl · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 death167 reports
- NA 04.614.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL80 reports
- NA 04.615.014Synthes GmbH · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- Arsenal Deformity Spinal Fixation System 47127Alphatec Spine, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL66 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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