Superion™ SUI 102-9800Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00884662000574), received between Apr 10, 2020 and Jun 19, 2025 — classified as 17 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (106 reports).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (P140004); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Jun 6, 2025Open, Classified

   As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

   Z-2485-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. May 12, 2023Open, Classified

   Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

   Z-1972-2023 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Material Integrity Problem; Material Twisted/Bent; Physical Resistance/Sticking; Material Integrity Problem; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TIPS OF THE DRIVER SHEARED DURING A PROCEDURE TO IMPLANT THE SUPERION INDIRECT DECOMPRESSION SPACER. ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THERE WAS SCAR TISSUE AND OSTEOPHYTES, AND ACCORDING TO THE PHYSICIAN, ABNORMAL BONE FORMATION THAT PROVIDED RESISTANCE WHEN OPENING THE SPACER. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE DAMAGE TO THE DRIVER, NOR WAS THE DEVICE RETURNED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22290479 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DEPLOYMENT THE WELDING CAP POPPED, AND DEVICE STRIPPED. UPON REMOVAL OF THE IMPLANT, THE TEETH OF THE DRIVER WERE ALSO FOUND TO BE STRIPPED. TROUBLESHOOTING INCLUDED REMOVAL OF THE DAMAGED DRIVER AND REPLACEMENT WITH NEW EQUIPMENT. THERE WERE NO INDICATIONS OF EXCESSIVE FORCE, SAGITTAL WIGGLE, OR GEAR-SHIFTING DURING THE PROCEDURE. ALL IMPLANTS AND BROKEN PIECES WERE SUCCESSFULLY REMOVED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179104 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, DIFFICULTIES OCCURRED DURING THE IMPLANT DEPLOYMENT, REQUIRING MULTIPLE REPOSITIONING ATTEMPTS TO PROPERLY ALIGN THE INSERTER WITH THE SPINOUS PROCESS. JUST BEFORE MAKING ANOTHER ADJUSTMENT, A NOISE WAS HEARD, AND UPON INSPECTION, THE DRIVER WAS FOUND TO BE BROKEN. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT, AND A NEW DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ISSUES POSTOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179073 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT PRIOR TO COMPLETING THE SUPERION INDIRECT DECOMPRESSION (ID) PROCEDURE, X-RAY IMAGING REVEALED ARTIFACTS NEXT TO THE IMPLANTS SPINDLE CAP. THE PHYSICIAN ASSESSED THAT THE DRIVER PRONGS HAD SHEARED OFF NEXT TO THE ID IMPLANT. THE PHYSICIAN USING FORCEPS, CONFIRMED ALL DRIVER PIECES WERE REMOVED BEFORE COMPLETING THE PROCEDURE. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179062 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE THE DRIVER BROKE. THE BROKEN FRAGMENT OF THE DRIVER AND IMPLANT WERE REMOVED, AND A NEW DRIVER AND IMPLANT WERE DEPLOYED SUCCESSFULLY. THE PATIENT WAS NOT REPORTED TO HAVE EXPERIENCED ANY COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179059 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THERE WERE DIFFICULTIES DEPLOYING THE IMPLANT, ACCOMPANIED BY A CRACKING SOUND, AFTER WHICH THE IMPLANT WOULD NO LONGER TURN. THE DRIVER HAD BROKEN, AND FRAGMENTS BECAME LODGED IN THE IMPLANT. THERE WERE NO SIGNS OF EXCESSIVE FORCE, SAGITTAL MOVEMENT, OR GEAR-SHIFTING DURING THE PROCEDURE, HOWEVER RESISTANCE MAY HAVE BEEN CAUSED BY THICK BONE OR OSTEOPHYTES. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179054 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, WHEN DEPLOYING THE DRIVER, THE TIP BENT, RESISTANCE WAS LOST, AND IT WAS THOUGHT THE DRIVER TIP BROKE OFF. THE BROKEN FRAGMENTS FROM THE DEVICES WERE REMOVED FROM THE PATIENT. A NEW DRIVER WAS USED TO IMPLANT THE DEVICE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179052 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER TIP BROKE OFF DURING IMPLANTATION. THE CAUSE OF THE BREAKAGE IS UNCLEAR HOWEVER THE USE OF EXCESSIVE FORCE WAS NOTED. THE BROKEN DRIVER FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT COMPLICATIONS. THE BROKEN DRIVER WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178920 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION (ID) PROCEDURE, THE DRIVER TIP/S BROKE OFF WHILE PUSHING THE DILATOR DOWN AND DEPLOYING THE IMPLANT. THE PHYSICIAN RETRIEVED THE BROKEN DRIVER PIECES AND COMPLETED THE PROCEDURE USING ANOTHER DRIVER OF THE SAME MODEL. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178917 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION (ID) PROCEDURE, THE DRIVER TIPS BROKE OFF DURING DEPLOYMENT OF THE IMPLANT. THE PHYSICIAN CONFIRMED THAT THE BROKEN DRIVER PIECE WAS REMOVED AND COMPLETED THE PROCEDURE USING ANOTHER DRIVER OF THE SAME MODEL. ANALYSIS OF THE DRIVER WAS NOT PERFORMED AS IT WAS RETAINED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178915 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER TEETH BROKE OFF. THERE WERE NO INDICATIONS OF EXCESSIVE FORCE, SAGITTAL WIGGLE, OR GEAR-SHIFTING DURING THE PROCEDURE. ALL BROKEN PIECES WERE REMOVED. THE BROKEN DRIVER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178914 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER CRACKED AND TWO OF THE TEETH WERE MISSING OFF THE DRIVER. THE BROKEN FRAGMENTS WERE SUCCESSFULLY RETRIEVED. IT SEEMED AS IF THERE WAS A LOT OF FORCE WHEN TRYING TO OPEN IT AS ONE OF THE LOBES WAS STILL CATCHING ON THE SPINOUS PROCESS. THE BROKEN DRIVER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. POST OPERATIVELY, THE PATIENT WAS DOING WELL IN RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178913 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE THE DRIVER BROKE, AND TWO END PIECES REMAINED IN THE IMPLANT. THE PHYSICIAN WAS ULTIMATELY ABLE TO RETRIEVE ALL BROKEN PIECES, AND A FINAL X-RAY CONFIRMED THAT NOTHING REMAINED IN THE PATIENT. THE IMPLANT PROCEDURE WAS COMPLETED WITH NEW DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178911 ↗
• InjuryJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION INDIRECT DECOMPRESSION SYSTEM IMPLANT PROCEDURE, BOTH DRIVER TIPS BROKE AND BECAME STUCK IN THE IMPLANT DURING DEPLOYMENT. ONE OF THE DRIVER TIPS WAS SUCCESSFULLY REMOVED BY THE IMPLANTING PHYSICIAN; HOWEVER, THE SECOND DRIVER TIP COULD NOT BE RETRIEVED, AND THE ENTIRE IMPLANT HAD TO BE REMOVED. IN THE PROCESS OF REMOVAL, THE LUMBER FOUR SUPERIOR SPINOUS PROCESS WAS BROKEN OFF.

  Patient problems: Vertebral Fracture

  MAUDE report 22178907 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER TIP BROKE OFF DURING IMPLANTATION. THE BROKEN DRIVER FRAGMENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT COMPLICATIONS. THE BROKEN DRIVER WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178906 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE PRONGS OF THE DRIVER BROKE DURING DEPLOYMENT OF THE IMPLANT. THE PHYSICIAN ASSESSED THAT THIS DAMAGE WAS DUE TO THE PATIENT'S NARROW ANATOMY WHICH CAUSED SOME RESISTANCE. ALL BROKEN PIECES OF THE DRIVER WERE REMOVED FROM THE PATIENT SUCCESSFULLY; HOWEVER, THE PROCEDURE WAS ABORTED DUE TO THE PATIENT'S DIFFICULT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178900 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) PROCEDURE, TO REMOVE THE IMPLANT (SEE MFR. 3006630150-2021-01478) THE TEETH SNAPPED OFF OF THE DRIVER. THE REMNANT PIECES WERE REMOVED, AND A NEW DRIVER WAS USED TO COMPLETE THE PROCEDURE. THE DRIVER WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178896 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, RESISTANCE WAS ENCOUNTERED WITH MANY OSTEOPHYTES AND THE DRIVER TIP BROKE. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE BROKEN DRIVER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE BROKEN DRIVER WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178889 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER TIP BROKE. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED. THE BROKEN DRIVER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178883 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE THE DRIVER WAS CAUGHT UP ON AN OBSTRUCTION. AS A RESULT, SAGITTAL ARCHING AND EXCESSIVE FORCE WERE APPLIED, CAUSING THE DRIVER TO BREAK. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED. ADDITIONALLY, THE IMPLANT WAS NOT DEPLOYING PROPERLY AND WAS GETTING STUCK. THE PATIENT DID NOT EXPERIENCE ANY REPORTED COMPLICATIONS. THE DAMAGED PRODUCT WAS REPLACED AND RETURNED FOR ANALYSIS, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178882 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DRIVER BROKE DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE. ALL BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW DRIVER. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178879 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A DECOMPRESSION SYSTEM DRIVER BROKE DURING A SURGICAL PROCEDURE. MULTIPLE REQUESTS WERE MADE FOR INFORMATION, HOWEVER A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178878 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE PRONGS OF THE DRIVER BROKE DURING DEPLOYMENT OF THE IMPLANT. THE PHYSICIAN ASSESSED THAT THIS DAMAGE WAS DUE TO THE PATIENTS NARROW ANATOMY WHICH CAUSED SOME RESISTANCE. ALL BROKEN PIECES OF THE DRIVER WERE REMOVED FROM THE PATIENT SUCCESSFULLY HOWEVER, THE PROCEDURE WAS ABORTED DUE TO THE PATIENTS DIFFICULT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178876 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER TIP BROKE OFF DURING IMPLANTATION. THE BROKEN DRIVER FRAGMENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT COMPLICATIONS. THE BROKEN DRIVER WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178875 ↗
• MalfunctionJun 10, 2025Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SYSTEM (IDS) IMPLANT PROCEDURE, THE DRIVER PRONGS BROKE OFF AND BECAME LODGED IN THE INSERTER AFTER THE SPACER WAS PLACED. THE PHYSICIAN HAD DIFFICULTY REMOVING THE DRIVER FROM THE INSERTER AND THE BROKEN OFF DRIVER PRONGS WERE SUCCESSFULLY FLUSHED AND SUCTIONED OUT OF THE PATIENT WHICH PROLONGED THE PROCEDURE BY FIFTEEN MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140004. One submission often covers many models, so check the product and lot details in each record.

• Z-0230-2023 · Oct 12, 2022 · Open, Classified
  Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm