Superion™ 101-9812Recalls & reported problems

Summary

The FDA's MAUDE database contains 810 adverse event reports that list this exact device (DI 00884662000543), received between Feb 4, 2020 and Mar 20, 2026 — classified as 240 injuries, 570 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (528 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

2. Oct 12, 2022Open, Classified

   Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap from the main body it may prevent proper deployment of the device during implantation.

   Z-0230-2023 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 810 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD THEIR SUPERION INTERSPINOUS SPACER DEVICE WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING PAIN WHILE WALKING. THE PAIN IS ATTRIBUTED TO THE SUPERION IMPLANT.

  Patient problems: Pain

  MAUDE report 24656216 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD THEIR SUPERION INTERSPINOUS SPACER DEVICE WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING PAIN WHILE WALKING. THE PAIN IS ATTRIBUTED TO THE SUPERION IMPLANT.

  Patient problems: Pain

  MAUDE report 24215477 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Lack of Effect; Adverse Event Without Identified Device or Use Problem; Lack of Effect

  IT WAS REPORTED THAT A PATIENT HAD THEIR SUPERION INTERSPINOUS SPACER DEVICE EXPLANTED FOR UNKNOWN REASONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547070 ↗
• InjuryNov 12, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SUPERION IMPLANT EXPERIENCED A LACK OF THERAPY FROM THE DEVICE, AS THEIR RECURRENT LATERAL RECESS STENOSIS SYMPTOMS IN THE LEGS HAD RETURNED. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE DEVICE, BUT THE EXPLANT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN CHOSE TO IMPLANT A NON-BSC DEVICE INSTEAD, WHICH RESOLVED THE PATIENT'S LEG SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538722 ↗
• MalfunctionNov 6, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR AND SOME SCRAPES ON THE CAM LOBES. THE DAMAGE TO THE IMPLANT INDICATES FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE AND/OR MANIPULATION OF THE POSITION OF THE DEVICE BY GEAR SHIFTING OF THE INSERTER. 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. SHOULD ANY RESISTANCE BE ENCOUNTERED DURING DEPLOYMENT OF THE SUPERION IMPLANT, IT MAY BE SUGGESTIVE OF INTERFERENCE BETWEEN THE IMPLANT AND BONY ANATOMY SUCH AS LAMINA, HYPERTROPHIC SPINOUS PROCESS, AND/OR SUBOPTIMAL IMPLANT POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493524 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING AN IMPLANT PROCEDURE. AS THE PHYSICIAN ATTEMPTED TO TAMP DOWN THE SPACER TOWARD THE END OF THE PROCEDURE, THE BOTTOM SET OF CAM LOBES BROKE OFF. IT WAS NOTED THERE MAY HAVE BEEN OSTEOPHYTES CAUSING RESISTANCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433374 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS OF THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE IMPLANT FAILED FUNCTIONAL TESTING. THE CAM LOBES DEPLOYED IN A NON-UNIFORM PATTERN, WITH A NOTICEABLE DELAY IN THE DEPLOYMENT OF THE SUPERIOR CAM LOBE. ALTHOUGH THE IMPLANT ULTIMATELY DEPLOYED COMPLETELY AND SUCCESSFULLY, THE SUPERIOR CAM LOBE SHOWED RESISTANCE TO ROTATING FREELY AROUND THE PIVOT PIN. MICROSCOPIC EXAMINATION INDICATED DAMAGE TO THE ACTUATOR AT ITS MATING SURFACE, ALONG WITH EVIDENCE OF SPINDLE BURNISHING CONSISTENT WITH ENGAGEMENT BY THE DRIVER. THE REPRESENTATIVE CONFIRMED THE PRESENCE OF DENSE BONE, WHICH MAY HAVE LED THE USER TO APPLY EXCESSIVE FORCE DURING IMPLANTATION. THIS SUSPICION IS SUPPORTED BY THE OBSERVED DAMAGE TO THE ACTUATOR AND SPINDLE, AS REPEATED DEPLOYMENT ATTEMPTS UNDER SUCH CONDITIONS CAN CAUSE SIGNIFICANT WEAR ON THE PIVOT PINS, RESULTING IN CAM LOBE MALFUNCTION. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEALED 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 T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433355 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A DAMAGED PIVOT PIN AND A DETACHED CAM LOBE AS WELL AS ABRASIONS/SCRATCHES ON THE BODY OF IMPLANT AND CAM LOBE. THIS DAMAGE SUGGESTS THAT THE USER EXERTED EXCESSIVE FORCE WHILE ATTEMPTING TO DEPLOY THE IMPLANT AGAINST RESISTANCE OR A RIGID OBSTRUCTION SUCH AS A SPINOUS PROCESS. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEALED 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 23433310 ↗
• MalfunctionOct 30, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THE CAM LOBE WAS BENT OUTWARD. THE DAMAGE TO THE IMPLANT WAS DUE TO THE USE OF EXCESSIVE FORCE WHEN THE IMPLANT WAS AGAINST A RIGID OBSTRUCTION WHEN ATTEMPTING TO DEPLOY THE IMPLANT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23433309 ↗
• MalfunctionOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED SOME SCRAPES ON THE CAM LOBES OF THE IMPLANT. THE IMPLANT FUNCTIONED ACCEPTABLY DURING THE FUNCTIONAL TEST. THESE ANOMALIES ARE LIKELY TO HAVE OCCURRED DUE TO THE ANATOMICAL CONDITIONS ENCOUNTERED DURING THE PROCEDURE. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEALED 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 23433265 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; 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 BONE SPUR WHICH CAUSED RESISTANCE; NO EXCESSIVE FORCE WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431355 ↗
• MalfunctionOct 30, 2025Use of Device Problem; Use of Device Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY DETACHED FROM THE IMPLANT BODY AND ACTUATOR SHAFT AND SPINDLE WERE NOT RETURNED. THE DAMAGE WAS SUFFICIENT TO PRECLUDE FUNCTIONAL TESTING. THE DAMAGE TO IMPLANT INDICATED A FAILURE, LIKELY DUE TO A COMBINATION OF DEPLOYMENT AGAINST RESISTANCE (E.G., BONE) AND/OR MANIPULATION OF THE POSITION OF THE DEVICE BY GEAR SHIFTING OF THE INSERTER. 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATE THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23431109 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY DETACHED OFF FROM THE IMPLANT BODY. THE DAMAGE TO IMPLANT INDICATED A FAILURE, 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATE THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23431093 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; 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 AND MAY HAVE CAUSED RESISTANCE; NO EXCESSIVE FORCE WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431091 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. THE DAMAGE WAS SUFFICIENT TO PRECLUDE FUNCTIONAL TESTING. THE DAMAGE TO IMPLANT INDICATED A FAILURE, 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATE THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23430869 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SUPERION INDIRECT DECOMPRESSION IMPLANT PROCEDURE, THE PHYSICIAN HAD TROUBLE OPENING THE SPACER. THE IMPLANT WAS REMOVED FROM THE INSERTER, AND THE WASHER FELL OFF. THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE PHYSICIAN NOTED COMPLEX PATIENT ANATOMY AND EXCESSIVE FORCE WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430865 ↗
• MalfunctionOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. THE DAMAGE TO IMPLANT INDICATES FAILURE WAS LIKELY DUE TO A COMBINATION OF DEPLOYMENT AGAINST RESISTANCE (E.G., BONE) AND 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATES THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23430864 ↗
• MalfunctionOct 30, 2025Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY DETACHED FROM THE IMPLANT BODY. THE DAMAGE TO IMPLANT INDICATES A FAILURE, 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATE THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23430811 ↗
• MalfunctionOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. THE DAMAGE WAS SUFFICIENT TO PRECLUDE FUNCTIONAL TESTING. THE DAMAGE TO IMPLANT INDICATED A FAILURE, 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATE THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23430803 ↗
• MalfunctionOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THE SCREW THREAD WAS STRIPPED AND THE ACTUATOR EXHIBITED A SEVERE ABRASION ON THE MATING SURFACE. THE DAMAGE TO THE IMPLANT INDICATES THAT EXCESSIVE FORCE WAS USED DURING DEPLOYMENT. 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 APPLICATION OF EXCESSIVE STRESS ON INSTRUMENTATION SHOULD BE AVOIDED; AND IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, OR IF THE DEVICE POSITION IS SUBOPTIMAL, COMPLETELY CLOSE THE IMPLANT BEFORE REPOSITIONING AND REDEPLOYING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430671 ↗
• MalfunctionOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT THE SPINDLE CAP WAS COMPLETELY SHEARED OFF FROM THE IMPLANT BODY. THE DAMAGE WAS SUFFICIENT TO PRECLUDE FUNCTIONAL TESTING. THE DAMAGE TO IMPLANT INDICATED A FAILURE, 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 REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE STATE THAT DEPLOYMENT SHOULD NOT BE FORCED OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT. FURTHERMORE, IF RESISTANCE TO DEPLOYMENT IS ENCOUNTERED, AND REPOSITIONING OF THE IMPLANT IS REQUIRED, THE DRIVER SHOULD BE ROTATED 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 23430668 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Difficult to Open or Close; Material Integrity Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE SUPERION IMPLANT PROCEDURE, THE SPACER BROKE DURING DEPLOYMENT. THE SPACER CAM LOBES WOULD NOT OPEN SYMMETRICALLY. IMAGING DID NOT SHOW EVIDENCE OF BONEY ANATOMY OR MISALIGNMENT. THE PHYSICIAN REMOVED THE SPACER AND DID NOT SEE ANY ANOMALIES, SO THE SPACER WAS REDEPLOYED. THE SPACER DID NOT FULLY OPEN, WAS REMOVED AGAIN FOR INSPECTION, AND APPEARED BENT. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430664 ↗
• 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 23430342 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  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 23430339 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING AN IMPLANT PROCEDURE. UPON DEPLOYMENT, AN AUDIBLE CRACK WAS HEARD, AND FURTHER DEPLOYMENT WAS NOT POSSIBLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430337 ↗

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