POLARIS 5.5 SPINAL SYSTEMRecalls & reported problems across all models

We found 17 models of POLARIS 5.5 SPINAL SYSTEM by Biomet Spine LLC in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2021 and Jan 13, 2026 — classified as 25 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (19 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

Most reported POLARIS 5.5 SPINAL SYSTEM problems

POLARIS 5.5 SPINAL SYSTEM models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• POLARIS™ 5.5 SPINAL SYSTEM 2000-1005

  Thoracolumbosacral pedicle screw system
  43 reports
• POLARIS™ 5.5 SPINAL SYSTEM 14-578540

  Appliance, fixation, spinal intervertebral body
  5 reports
• POLARIS™ 5.5 SPINAL SYSTEM 2000-2445

  Appliance, fixation, spinal intervertebral body
  4 reports
• POLARIS™ 5.5 SPINAL SYSTEM 2000-2335

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  3 reports
• POLARIS™ 5.5 SPINAL SYSTEM 14-578445

  Orthosis, spondylolisthesis spinal fixation
  3 reports
• POLARIS 5.5 SPINAL SYSTEM 2000-2450

  Orthosis, spondylolisthesis spinal fixation
  3 reports
• POLARIS™ 5.5 SPINAL SYSTEM 14-500591

  Appliance, fixation, spinal intervertebral body
  2 reports
• Polaris™ 5.5 Spinal System 94672

  Thoracolumbosacral pedicle screw system
  2 reports
• POLARIS™ 5.5 SPINAL SYSTEM 2000-2540

  Thoracolumbosacral pedicle screw system
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 2000-2535

  Orthosis, spinal pedicle fixation
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 2000-2345

  Thoracolumbosacral pedicle screw system
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 2000-2140

  Orthosis, spinal pedicle fixation
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 2000-1008

  Thoracolumbosacral pedicle screw system
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 14-578680

  Pedicle screw spinal system, adolescent idiopathic scoliosis
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 14-578670

  APPLIANCE, FIXATION, SPINAL INTERLAMINAL
  1 report
• POLARIS™ 5.5 SPINAL SYSTEM 14-578535

  Orthosis, spondylolisthesis spinal fixation
  1 report
• Polaris™ 5.5 Spinal System 94671

  Thoracolumbosacral pedicle screw system
  1 report

Recent POLARIS 5.5 SPINAL SYSTEM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS PSEUDOARTHROSIS AT THE TOP AND BOTTOM LEVELS OF AN L1-S1 PEDICLE SCREW CONSTRUCT. THE CONSTRUCT WAS REMOVED AND REPLACED DURING THE REVISION, EXCEPT FOR BOTH THE SCREWS AT L5 WHICH COULD NOT BE REMOVED DUE TO A BROKEN DRIVER. THIS IS REPORT ELEVEN OF EIGHTEEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24058671 ↗
• InjuryJan 13, 2026Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS PSEUDOARTHROSIS AT THE TOP AND BOTTOM LEVELS OF AN L1-S1 PEDICLE SCREW CONSTRUCT. THE CONSTRUCT WAS REMOVED AND REPLACED DURING THE REVISION, EXCEPT FOR BOTH THE SCREWS AT L5 WHICH COULD NOT BE REMOVED DUE TO A BROKEN DRIVER. THIS IS REPORT TEN OF EIGHTEEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24058610 ↗
• InjuryJan 13, 2026Failure to Osseointegrate

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS PSEUDOARTHROSIS AT THE TOP AND BOTTOM LEVELS OF AN L1-S1 PEDICLE SCREW CONSTRUCT. THE CONSTRUCT WAS REMOVED AND REPLACED DURING THE REVISION, EXCEPT FOR BOTH THE SCREWS AT L5 WHICH COULD NOT BE REMOVED DUE TO A BROKEN DRIVER. THIS IS REPORT NINE OF EIGHTEEN FOR THIS EVENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24058521 ↗
• MalfunctionJan 9, 2026Material Deformation

  IT WAS REPORTED THAT THE INNER HEXAGON OF A POLARIS 5.5 DEROTATION PLUG WAS DAMAGED WHEN ATTEMPTING TO TIGHTEN IT. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023354 ↗
• MalfunctionNov 5, 2025Wrong Label; Wrong Label

  A DISTRIBUTOR REPORTED THAT THEY RECEIVED TWO POLARIS 5.5 CROSS CONNECTORS THAT DIFFERED FROM THE PACKAGING LABELS. THE CONNECTORS INSIDE THE PACKAGES WERE NOT SIZE M, AS INDICATED, BUT SIZE XS. THIS WAS DISCOVERED PRIOR TO SURGICAL USE AND THERE WAS NO PATIENT IMPACT. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479711 ↗
• MalfunctionNov 5, 2025Wrong Label; Wrong Label

  A DISTRIBUTOR REPORTED THAT THEY RECEIVED TWO POLARIS 5.5 CROSS CONNECTORS THAT DIFFERED FROM THE PACKAGING LABELS. THE CONNECTORS INSIDE THE PACKAGES WERE NOT SIZE M, AS INDICATED, BUT SIZE XS. THIS WAS DISCOVERED PRIOR TO SURGICAL USE AND THERE WAS NO PATIENT IMPACT.THIS IS REPORT ONE OF TWO FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479654 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT TWELVE OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981376 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT ELEVEN OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981235 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT TEN OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981176 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT NINE OF TWENTY SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981136 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT EIGHT OF TWENTY SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981100 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT SEVEN OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981055 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT SIX OF TWENTY SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21981047 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT FIVE OF TWENTY SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21980979 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE AN HA COATED PEDICLE SCREW CONSTRUCT FROM LEVELS L1 THROUGH S1 BECAUSE THE HARDWARE WAS CAUSING THE PATIENT PAIN. THE PATIENT HAD SOLIDLY FUSED PRIOR TO THE REVISION SO THE CONSTRUCT WAS NO LONGER OF USE AND WAS NOT REPLACED WITH ANY OTHER HARDWARE. ONE OF THE SCREWS ON THE BOTTOM OF THE CONSTRUCT WAS UNABLE TO BE REMOVED BECAUSE THE TIP OF THE HEIGHT ADJUSTER BROKE OFF IN THE SCREW HEAD. THIS IS REPORT FOUR OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21980903 ↗

Other Biomet Spine LLC products

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