Superion™ 101-9816Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00884662000567), received between Feb 4, 2020 and Oct 31, 2025 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls 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 ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS OF THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT, ALTHOUGH THE IMPLANT DEPLOYED FULLY AND SUCCESSFULLY, BOTH THE SUPERIOR AND INFERIOR CAM LOBES SHOWED RESISTANCE TO ROTATING FREELY AROUND THE PIVOT PIN. MICROSCOPIC EXAMINATION INDICATED SEVERE DAMAGE TO THE ACTUATOR AT ITS MATING SURFACE. THE PATIENTS REPORTEDLY THICK SPINOUS PROCESS AND LIMITED SPACE LIKELY CREATED CONDITIONS THAT LED THE USER TO APPLY EXCESSIVE FORCE ON THE INSERTER AND IMPLANT. THIS UNDUE FORCE IS SUPPORTED BY THE OBSERVED ACTUATOR DAMAGE. UNDER SUCH CIRCUMSTANCES, REPEATED DEPLOYMENT ATTEMPTS CAN CAUSE SIGNIFICANT WEAR ON THE PIVOT PINS, ULTIMATELY RESULTING IN CAM LOBE MALFUNCTION. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IT STATES THAT IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, ROTATE THE DRIVER COUNTERCLOCKWISE UNTIL A POSITIVE STOP IS REACHED AND WITHDRAW DORSALLY TO COLLAPSE THE CAM LOBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437661 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SUPERION INDIRECT DECOMPRESSION BROKE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE PATIENT'S ANATOMY WAS CHALLENGING AS IT CONSISTED OF A THICK SPINOUS PROCESS WITH OSTEOPHYTIC GROWTH; NO EXCESSIVE FORCE WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430868 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SUPERION INDIRECT DECOMPRESSION BROKE DURING DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE PATIENTS ANATOMY WAS CHALLENGING AS IT CONSISTED OF A THICK SPINOUS PROCESS WITH OSTEOPHYTIC GROWTH; NO EXCESSIVE FORCE WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430860 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. AFTER FULLY DEPLOYING THE IMPLANT THE PHYSICIAN WENT TO MALLET THE IMPLANT TO THE LAMINA AND AT THE TIME THE TOP LEGS BROKE OFF. THE BROKEN SPACER WAS REMOVED AND A NEW WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430229 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. AFTER FULLY DEPLOYING THE IMPLANT THE PHYSICIAN WENT TO MALLET THE IMPLANT WHEN THE SUPERIOR CAM LOBES BROKE OFF IN A BACKWARDS DIRECTION, FULLY SEPARATING FROM THE BODY OF THE IMPLANT. THE PHYSICIAN REMOVED THE CANNULA AND USED GRASPING RASPS TO RETRIEVE BOTH THE UPPER LOBE SECTION AND THE REST OF THE IMPLANT. A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430224 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER. VISUAL INSPECTION SHOWED THAT THE IMPLANT HAD SUFFERED SIGNIFICANT DAMAGE AS THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. THE DAMAGE WAS SUFFICIENT TO PRECLUDE FUNCTIONAL TESTING. THE DAMAGE INDICATES THIS FAILURE WAS LIKELY DUE TO A COMBINATION OF DEPLOYMENT AGAINST RESISTANCE (E.G. BONE) AND THE PHYSICIAN FAILING TO CORRECTLY ATTACH THE INSERTER TO THE SPACER. PRODUCT ANALYSIS CONFIRMED THAT THE MOST PROBABLE CAUSE OF THE COMPLAINT IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEAL NO ANOMALIES. THE INSTRUCTIONS FOR USE (IFU) STATES DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IT STATES THAT IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, ROTATE THE DRIVER COUNTERCLOCKWISE UNTIL A POSITIVE STOP IS REACHED AND WITHDRAW DORSALLY TO COLLAPSE THE CAM LOBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429895 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING AN IMPLANT PROCEDURE. ALL PIECES WERE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THE IMPLANT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302490 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THIS WAS NOT THE FAULT OF THE PHYSICIAN. NO DAMAGE TO THE PATIENT, AS THE PATIENT IS REPORTEDLY DOING WELL. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS NOT RELEASED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301814 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE. THE SPACER WAS REPLACED WITH A NEW ONE DURING THE PROCEDURE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301201 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE. THE BROKEN COMPONENTS OF THE SPACER WERE REMOVED. THE PHYSICIAN WAS CAUTIONED NOT TO OVERSIZE THE SPACER BUT PROCEEDED WITH THE 16MM SPACER ANYWAY. THE PATIENT'S ANATOMY DID NOT CONSIST OF THICK BONE, OSTEOPHYTES, OR OTHER OBSTRUCTIONS; EXCESSIVE FORCE WAS USED DURING THE IMPLANT PROCEDURE AS THE SPACER HAD BEEN OVERSIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290073 ↗
• MalfunctionNov 17, 2023Device Fell; Device Fell

  IT WAS REPORTED THAT THE INDIRECT DECOMPRESSION (ID) SPACER WAS DROPPED IN THE OPERATING ROOM (OR) AND THERE WAS NO DEVICE ISSUE. DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED IMPLANT AND REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY AND THERE WAS SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR. THIS DAMAGE TO THE IMPLANT INDICATES THE BREAK WAS DUE TO BOTH THE DEPLOYMENT AGAINST RESISTANCE, SUCH AS BONE, AND NOT CORRECTLY ATTACHING THE INSERTER TO THE SPACER. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. ADDITIONALLY, DEVICE BREAKAGE CAN OCCUR WHEN USED WITH FORCED DEPLOYMENT AND IS NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165335 ↗
• MalfunctionSep 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE THE SPINDLE CAP BROKE. IT WAS NOTED THAT THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE. THERE WAS THICK BONE AS WELL AS OSTEOPHYTES WHICH CAUSED RESISTANCE. IT WAS ASSESSED THAT MULTIPLE DEPLOYMENTS LED TO THE IMPLANT BREAKING. THERE WERE NO BROKEN PIECES LEFT INSIDE THE PATIENT. A DIFFERENT SPACER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE SPACER WILL NOT BE RETURNED AS IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787213 ↗
• MalfunctionSep 20, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE THE SPINDLE CAP BROKE. IT WAS NOTED THAT THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE. THERE WAS THICK BONE AS WELL AS OSTEOPHYTES WHICH CAUSED RESISTANCE. IT WAS ASSESSED THAT MULTIPLE DEPLOYMENTS LED TO THE IMPLANT BREAKING. THERE WERE NO BROKEN PIECES LEFT INSIDE THE PATIENT. A DIFFERENT SPACER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE SPACER WILL NOT BE RETURNED AS IT WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785995 ↗
• MalfunctionMar 9, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. DAMAGE TO DEVICE INDICATES THE BREAKAGE WAS DUE TO A COMBINATION OF DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE, AND OR MANIPULATION OF THE POSITION OF THE DEVICE BY GEAR SHIFTING OF THE INSERTER. A LABELLING REVIEW WAS PERFORMED AND IT DID NOT REVEAL ANY ANOMALIES. ADDITIONALLY, DEVICE BREAKAGE CAN OCCUR WHEN USED WITH FORCED DEPLOYMENT WHICH IS NOTED WITHIN THE IFU AS A POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512966 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THEIR SPACER AS THE DEVICE WAS NOT HELPING THE PATIENT. IT WAS NOTED THAT IT HAS BEEN 2 YEARS SINCE THE INITIAL IMPLANT OF THE SPACER. THE EXPLANTED SPACER WAS RETAINED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13336938 ↗
• MalfunctionNov 29, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION INDIRECT DECOMPRESSION SYSTEM IMPLANT PROCEDURE, THE TOP OF THE SPACER BROKE OFF AND WOULD NO LONGER DEPLOY. THE SPACER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETELY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885310 ↗
• MalfunctionNov 29, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION INDIRECT DECOMPRESSION SYSTEM IMPLANT PROCEDURE, THE TOP OF THE SPACER BROKE OFF AND WOULD NO LONGER DEPLOY. THE SPACER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETELY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885264 ↗
• MalfunctionAug 5, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE THE PHYSICIAN HEARD A POP WHILE ATTEMPTING DEPLOYMENT AND THE IMPLANT WAS STRIPPED. THE DAMAGED IMPLANT WAS DISPOSED OF AT FACILITY AND WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285538 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR BACK AND LEG AREAS CAUSED BY THE SPACER. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE SPACER WAS REMOVED.

  Patient problems: Pain

  MAUDE report 11601684 ↗
• InjuryJan 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT HAD A FALL AFTER LIFTING SOMETHING HEAVY. THE PATIENT THEN EXPERIENCED LOSS OF EFFICACY. X-RAYS SHOWED THAT THE IMPLANT AT L3/4 HAD A BENT UPPER LEFT CAM LOBE AND THAT THE IMPLANT AT L4/5 HAD DISLODGED FROM THE INTERSPINOUS SPACE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IMPLANT AT L3/4 WAS REMOVED AND REPLACED WITH A NEW IMPLANT AND THE IMPLANT AT L4/5 WAS REMOVED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

  Patient problems: Fall; No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11121106 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHARP BACK PAIN AND LOSS OF PAIN RELIEF FOLLOWING HIS INITIAL SURGERY. THE PHYSICIAN ASSESSED THAT THE PATIENT HAD A FRACTURE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE IMPLANT AND IS DOING WELL POST-OPERATIVELY.

  Patient problems: Bone Fracture(s); No Code Available; Pain; Therapeutic Effects, Unexpected

  MAUDE report 11032551 ↗
• InjuryMar 26, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO THE SPACER BEING DISPLACED. THE SPACER WAS KEPT BY THE MEDICAL FACILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 9884827 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT FOLLOWING THE INITIAL IMPLANT OF A SPACER THE PHYSICIAN DECIDED TO TRY A LARGER SPACER. THE INITIAL SPACER WAS EXPLANTED AND WHILE TRYING TO IMPLANT A LARGER SPACER IT WAS DISCOVERED THAT THE IMPLANTING INSTRUMENTS WERE NOT HOLDING FIRM. THE PHYSICIAN REMOVED EVERYTHING FROM THE PATIENT AND IT WAS DETERMINED THERE WAS A SPINOUS PROCESS FRACTURE AT L4. THE PHYSICIAN DECIDED TO NOT IMPLANT THE PATIENT. THERE WERE NO INCREASED RISK FACTORS FOR A SPINOUS PROCESS FRACTURE. THERE WAS NO UNUSUAL OR CONTRAINDICATED ANATOMY AS WELL AS THERE WAS NO ASSOCIATED SIGNS OR SYMPTOMS OF A SPINOUS PROCESS FRACTURE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9663256 ↗

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-1972-2023 · May 12, 2023 · Open, Classified
  Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Techn
• 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