Superion™ 101-9810Recalls & reported problems

Summary

The FDA's MAUDE database contains 356 adverse event reports that list this exact device (DI 00884662000536), received between Nov 14, 2018 and Dec 11, 2025 — classified as 96 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (236 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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 356 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SUPERION INDIRECT DECOMPRESSION SYSTEM PATIENT STATED THEIR "VF PROCEDURE FAILED." NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED DESPITE GOOD FAITH EFFORT ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777687 ↗
• MalfunctionOct 31, 2025Material Twisted/Bent; Material Twisted/Bent

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THE RIGHT WING OF THE SUPERIOR CAM LOBE WAS SLIGHTLY BENT AWAY FROM THE MEDIAN LINE. THE IMPLANT DID NOT FUNCTION ACCEPTABLY UPON FUNCTIONAL TESTING SINCE THE IMPLANT DEPLOYED WITH EXCESSIVE RESISTANCE AND ONE OF THE CAM LOBES WOULD NOT RETRACT WITHOUT ADDITIONAL EFFORT. THE DAMAGE TO IMPLANT INDICATES THE OBSERVED DAMAGE WAS LIKELY DUE TO FORCED DEPLOYMENT AGAINST A RIGID OBSTRUCTION SUCH AS THE SPINOUS PROCESS. 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 23433383 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THE DEVICE DEPLOYED WITH RESISTANCE AND THE CAM-LOBES WOULD NOT RETRACT WITHOUT AN ADDITIONAL EFFORT. THIS DAMAGE IS LIKELY DUE TO THE USER EXERTING UNDUE FORCE ON THE IMPLANT WHICH RESULTED IN WEAR OF THE PIVOT PINS WHICH CAUSED THE MALFUNCTION OF THE CAM LOBES. 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 23433380 ↗
• 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 PARTIALLY SHEARED 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 23431102 ↗
• 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 23431100 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER WOULD NOT OPEN, AND THE PROCEDURE HAD TO BE ABORTED. THE PATIENTS ANATOMY WAS CHALLENGING AS THERE WAS LIMITED SPACE IN THE SPINOUS PROCESS. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE. THE BROKEN SPACER WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431097 ↗
• 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 PARTIALLY DETACHED 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). 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 23431096 ↗
• 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 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 23430859 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR AND BOTH SIDES OF THE ACTUATOR BODY. DURING FUNCTIONAL TESTING THE SPACER EXHIBITED SIGNIFICANT RESISTANCE TO DEPLOY DUE TO THE ABRASION ON THE ACTUATOR. 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. FURTHERMORE, IT STATES THAT 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 23430340 ↗
• 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 FOUND THAT THE LEFT SUPERIOR CAM LOBE WAS SLIGHTLY BENT AWAY FROM THE MEDIAN LINE AND SEVERE ABRASION WAS OBSERVED ON THE MATING SURFACE OF THE ACTUATOR. IN ADDITION, THE SPACER DEPLOYED WITH RESISTANCE AND THE INFERIOR CAM LOBE WOULD NOT RETRACT WITHOUT ADDITIONAL EFFORT DURING FUNCTIONAL TESTING. THIS EXCESSIVE FORCE RESULTED IN WEAR OF THE PIVOT PINS WHICH CAUSED THE MALFUNCTION OF THE CAM LOBES. 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 (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 23430197 ↗
• 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 23430043 ↗
• 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 23430039 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER. VISUAL INSPECTION SHOWED THAT THE SPINDLE CAP WAS CRACKED AT THE TOP EDGE OF LEG 3. THE DAMAGE INDICATES THIS FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE (E.G. BONE). 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 (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 23430034 ↗
• MalfunctionOct 30, 2025Nonstandard Device; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; 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 23429875 ↗
• 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 23429872 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR AND SEVERE SCRAPES ON ONE OF 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 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 23427953 ↗
• 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 A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR. THE DAMAGE TO THE IMPLANT SUGGESTS THAT THE USER LIKELY EXERTED EXCESSIVE FORCE WHILE ATTEMPTING TO DEPLOY THE IMPLANT AGAINST A RIGID OBSTRUCTION SUCH AS A SPINOUS PROCESS. ADDITIONALLY, A LABELING REVIEW WAS COMPLETED AND REVEALED THE INSTRUCTIONS FOR USE (IFU) STATES NOT TO FORCE DEPLOYMENT OR IMPLANT BREAKAGE OR DAMAGE TO BONY STRUCTURES MAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427521 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE INTO THREE PIECES DURING DEPLOYMENT. THE PATIENT HAD A LOT OF OSTEOPHYTES AND TIGHT SPACING. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE. THE BROKEN SPACER WAS REMOVED, AND A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393318 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SPACER. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE DEPLOYMENT. THE DEVICE WAS NOT RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392563 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN INDIRECT DECOMPRESSION SPACER IMPLANT PROCEDURE, THE SPINDLE CAP BROKE OFF THE SPACER. THERE WERE NO PATIENT COMPLICATIONS DUE TO THE EVENT. A NEW SPACER WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392406 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE AS THE SPINDLE CAP POPPED OFF. A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT REPORTEDLY HAD THICK SPINOUS PROCESS. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390411 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE WASHER ON THE SPACER STRIPPED AND BROKE. THICK BONE WAS NOTED AND THE PHYSICIAN USED MORE FORCE TO TRY DEPLOYING THE IMPLANT DUE TO THE OSTEOPHYTE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SPACER. THE BROKEN SPACER WAS NOT RETURNED TO BSC FOR ANALYSIS AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389926 ↗
• MalfunctionOct 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE CONNECTION BETWEEN THE SUPERION INDIRECT DECOMPRESSION SPACER AND THE DRIVER STRIPPED. A NEW IMPLANT WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384517 ↗
• MalfunctionOct 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING AN IMPLANT PROCEDURE. THE INTENDED PLACEMENT SITE WAS NOTED TO BE A VERY NARROW SPACE, WHICH CONTRIBUTED TO RESISTANCE DURING DEPLOYMENT. WHILE THE PHYSICIAN WAS PERFORMING SMALL, REPEATED SAGITTAL MOVEMENTS TO POSITION THE DEVICE, THE SPACER BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380523 ↗
• MalfunctionOct 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SPACER BROKE DURING DEPLOYMENT. UPON ASSESSMENT, IT WAS NOTED THAT THE SCREW APPEARED TO BE STRIPPED, WHICH PREVENTED THE DRIVER FROM ACHIEVING ADEQUATE TRACTION DURING THE DEPLOYMENT PROCESS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375893 ↗

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