POLARIS™ 5.5 SPINAL SYSTEM 2000-1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00880304925816), received between Jan 8, 2021 and Jan 13, 2026 — classified as 21 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (17 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 25 most recent of 43 reports, 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 ↗
• 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 ↗
• 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 THREE OF TWENTY SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21980825 ↗
• 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 TWO OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21980785 ↗
• 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 ONE OF TWENTY-SIX FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21980774 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SEVERAL YEARS AFTER AN L5-PELVIS POSTERIOR FUSION CONSTRUCT WAS IMPLANTED. A REVISION SURGERY WAS PERFORMED WHERE THE CONSTRUCT WAS REMOVED, EXCLUDING THE TWO SCREWS AT L5, WHICH HAD BEEN STRIPPED DURING INSTALLATION AND WERE UNABLE TO BE REMOVED. THIS IS REPORT TWELVE OF FOURTEEN FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21646769 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SEVERAL YEARS AFTER AN L5-PELVIS POSTERIOR FUSION CONSTRUCT WAS IMPLANTED. A REVISION SURGERY WAS PERFORMED WHERE THE CONSTRUCT WAS REMOVED, EXCLUDING THE TWO SCREWS AT L5, WHICH HAD BEEN STRIPPED DURING INSTALLATION AND WERE UNABLE TO BE REMOVED. THIS IS REPORT ELEVEN OF FOURTEEN FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21646748 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SEVERAL YEARS AFTER AN L5-PELVIS POSTERIOR FUSION CONSTRUCT WAS IMPLANTED. A REVISION SURGERY WAS PERFORMED WHERE THE CONSTRUCT WAS REMOVED, EXCLUDING THE TWO SCREWS AT L5, WHICH HAD BEEN STRIPPED DURING INSTALLATION AND WERE UNABLE TO BE REMOVED. THIS IS REPORT TEN OF FOURTEEN FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21646701 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SEVERAL YEARS AFTER AN L5-PELVIS POSTERIOR FUSION CONSTRUCT WAS IMPLANTED. A REVISION SURGERY WAS PERFORMED WHERE THE CONSTRUCT WAS REMOVED, EXCLUDING THE TWO SCREWS AT L5, WHICH HAD BEEN STRIPPED DURING INSTALLATION AND WERE UNABLE TO BE REMOVED. THIS IS REPORT NINE OF FOURTEEN FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21646617 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SEVERAL YEARS AFTER AN L5-PELVIS POSTERIOR FUSION CONSTRUCT WAS IMPLANTED. A REVISION SURGERY WAS PERFORMED WHERE THE CONSTRUCT WAS REMOVED, EXCLUDING THE TWO SCREWS AT L5, WHICH HAD BEEN STRIPPED DURING INSTALLATION AND WERE UNABLE TO BE REMOVED. THIS IS REPORT EIGHT OF FOURTEEN FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21646593 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH PAIN SEVERAL YEARS AFTER AN L5-PELVIS POSTERIOR FUSION CONSTRUCT WAS IMPLANTED. A REVISION SURGERY WAS PERFORMED WHERE THE CONSTRUCT WAS REMOVED, EXCLUDING THE TWO SCREWS AT L5, WHICH HAD BEEN STRIPPED DURING INSTALLATION AND WERE UNABLE TO BE REMOVED. THIS IS REPORT SEVEN OF FOURTEEN FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 21646577 ↗
• MalfunctionMar 18, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT FIVE OF TEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633301 ↗
• MalfunctionMar 18, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT FOUR OF TEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633295 ↗
• MalfunctionMar 18, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT THREE OF TEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633292 ↗
• MalfunctionMar 18, 2025Migration; Migration

  IT WAS REPORTED THAT DURING A POST-OP FOLLOW UP APPOINTMENT, FIVE PLUGS WERE FOUND TO HAVE MIGRATED OUT OF THEIR TRANSLATING SCREWS. THE AFFECTED LEVELS ARE LOCATED AT RIGHT L3, RIGHT AND LEFT L4, AND RIGHT AND LEFT PELVIS. THE PATIENT IS ASYMPTOMATIC, SO A REVISION SURGERY IS NOT PLANNED. THIS IS REPORT TWO OF TEN FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633287 ↗