Superion™ 101-9814Recalls & reported problems

Summary

The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 00884662000550), received between Feb 14, 2020 and Jun 29, 2026 — classified as 66 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (215 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 295 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2026Lack of Effect

  IT WAS REPORTED THAT THE PATIENT'S SUPERION INDIRECT DECOMPRESSION IMPLANT WAS EXPLANTED DUE TO INEFFECTIVELY TREATING THE PATIENT'S BACK PAIN. THE PATIENT HAS MADE A FULL RECOVERY FOLLOWING THE EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Back pain

  MAUDE report 25650394 ↗
• InjuryJun 29, 2026Migration; Lack of Effect

  IT WAS REPORTED THAT A PATIENT'S SUPERION INDIRECT DECOMPRESSION IMPLANT HAD MIGRATED, WHICH WAS CONFIRMED VIA FLUOROSCOPY. THE PATIENT HAD CONTINUED TO HAVE LOWER BACK PAIN, AND THE DEVICE WAS NOT EFFECTIVE TO TREAT THE PAIN. ACCORDING TO THE PHYSICIAN, IT WAS DIFFICULT TO DETERMINE IF THE MIGRATION OF THE IMPLANT CAUSED THE PAIN OR IF THE PAIN WAS UNRELATED TO THE DEVICE. THE DEVICE WAS EXPLANTED AND THE PATIENT HAS MADE A FULL RECOVERY FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

  Patient problems: Back pain

  MAUDE report 25650388 ↗
• InjuryMay 18, 2026Difficult to Open or Close; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF A SUPERION INDIRECT DECOMPRESSION SYSTEM IN ORDER TO UNDERGO A DIFFERENT PROCEDURE. THE PATIENT STILL HAD PAIN AND WAS NOT CLEAR IF THE DEVICE WAS WORKING AS INTENDED. THE PHYSICIAN TRIED TO BACK OUT SCREW, BUT THE CAM LOBES WOULD NOT RETRACT. THE PHYSICIAN SAID THE PATIENT HAS SCAR TISSUE AROUND THE DEVICES AND THEY WOULD NOT COME OUT. THE PHYSICIAN REMAINED CAUTIOUS AND DECIDED TO LEAVE THEM IMPLANTED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 25201476 ↗
• InjuryMay 18, 2026Difficult to Open or Close; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF A SUPERION INDIRECT DECOMPRESSION SYSTEM IN ORDER TO UNDERGO A DIFFERENT PROCEDURE. THE PATIENT STILL HAD PAIN AND WAS NOT CLEAR IF THE DEVICE WAS WORKING AS INTENDED. THE PHYSICIAN TRIED TO BACK OUT SCREW, BUT THE CAM LOBES WOULD NOT RETRACT. THE PHYSICIAN SAID THE PATIENT HAS SCAR TISSUE AROUND THE DEVICES AND THEY WOULD NOT COME OUT. THE PHYSICIAN REMAINED CAUTIOUS AND DECIDED TO LEAVE THEM IMPLANTED.

  Patient problems: Pain; Scar Tissue

  MAUDE report 25201470 ↗
• MalfunctionOct 30, 2025Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED THAT A CAM-LOBE WAS SIGNIFICANTLY BENT, AND A SEVERE ABRASION WAS OBSERVED ON THE MATING SURFACE OF THE ACTUATOR. THIS DAMAGE SUGGESTS THAT THE USER EXERTED EXCESSIVE FORCE WHILE ATTEMPTING TO DEPLOY THE IMPLANT AGAINST A RIGID OBSTRUCTION SUCH AS A SPINOUS PROCESS. A LABELING REVIEW WAS CONDUCTED AND REVEALED NO ANOMALIES. THE INSTRUCTIONS FOR USE (IFU) SPECIFY THAT DEPLOYMENT SHOULD NEVER BE FORCED, AS DOING SO MAY RESULT IN IMPLANT BREAKAGE OR DAMAGE TO SURROUNDING BONY STRUCTURES. IF RESISTANCE IS ENCOUNTERED DURING DEPLOYMENT OR IF THE DEVICE IS POSITIONED SUBOPTIMALLY, THE IMPLANT SHOULD BE COMPLETELY CLOSED BEFORE REPOSITIONING AND REDEPLOYING. ADDITIONALLY, THE IFU CAUTIONS AGAINST ATTEMPTING TO ADJUST THE DEVICE POSITION BY GEAR-SHIFTING THE INSERTER (I.E., GROSS CRANIAL, CAUDAL, OR LATERAL ARTICULATION). THE MECHANICAL LEVERAGE PROVIDED BY THE INSERTER LENGTH MAY BE SUFFICIENT TO DAMAGE THE IMPLANT OR ADJACENT ANATOMY. EXCESSIVE STRESS ON INSTRUMENTATION SHOULD ALSO BE AVOIDED. IF RESISTANCE OCCURS DURING DEPLOYMENT OF THE SUPERION IMPLANT, IT MAY INDICATE INTERFERENCE BETWEEN THE IM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432623 ↗
• 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 23430870 ↗
• MalfunctionOct 30, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device 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 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 23430807 ↗
• 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 THE SCREW THREAD WAS STRIPPED. THE DAMAGE TO THE IMPLANT INDICATES FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE. 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 23430663 ↗
• MalfunctionOct 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. THE PHYSICIAN WAS HITTING RESISTANCE AND WHEN HE WENT TO UN-DEPLOY AND PULL BACK A POPPING SOUND WAS HEARD. THE IMPLANT HAD BROKEN. A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430200 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; 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 23429975 ↗
• MalfunctionOct 30, 2025Difficult to Open or Close; Difficult to Open or Close

  DEVICE ANALYSIS ON THE RETURNED SUPERION INDIRECT DECOMPRESSION SPACER REVEALED A SEVERE ABRASION ON THE MATING SURFACE OF THE ACTUATOR, AND SEVERE SCRAPES WERE OBSERVED ON THE CAM LOBES. THE DAMAGE TO THE IMPLANT INDICATES FAILURE WAS LIKELY DUE TO DEPLOYMENT AGAINST RESISTANCE SUCH AS BONE. 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 23428734 ↗
• MalfunctionOct 30, 2025Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; 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. THIS IS EVIDENCE OF EXCESSIVE FORCE USED DURING DEPLOYMENT. 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 23427512 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. IT WAS BELIEVED THAT THE SIZE OF THE SPACER WAS TOO BIG FOR THE PATIENT'S ANATOMY AS IT KEPT SNAGGING THE 5TH LAMINA. IT WAS NOTED THAT THE PATIENT'S LAMINA WAS CAUSING RESISTANCE WHILE DEPLOYING. 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 NOT RELEASED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393309 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE. THE BROKEN SPACER COMPONENTS WERE REMOVED WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE PHYSICIAN NOTED THE PATIENT ANATOMY CONSISTED OF THICK BONE WHICH MAY HAVE CAUSED RESISTANCE; AND THAT NO EXCESSIVE FORCE WAS USED DURING THE IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392550 ↗
• MalfunctionOct 27, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. THE SPACER WOULD NOT FULLY DEPLOY AND UPON REMOVAL, IT WAS DISCOVERED THAT THE BACK PORTION OF THE SPACER WAS NO LONGER FUNCTIONING. IT WAS NOTED THAT THERE WAS A COMBINATION OF SHALLOW INTERSPINOUS SPACE AND TOUGH ANATOMY. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE. THE BROKEN SPACER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SPACER. THE DEVICE WAS NOT RETURNED FOR ANALYSIS DESPITE MULTIPLE GOOD FAITH EFFORTS PERFORMED TO RETURN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390897 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. THE PHYSICIAN WAS IMPLANTING IN A SMALL TIGHT SPACE IN THE SPINOUS PROCESS. THE PHYSICIAN DECIDED TO DO A SAGITTAL WIGGLE TO LOOSEN THINGS UP AND THE TOP OF THE SPACER BROKE OFF FROM THE INSERTER. THE BROKEN SPACER WAS REPLACED WITH A NEW ONE. THE PATIENT'S ANATOMY WAS NOTED TO HAVE OSTEOPHYTES AND A THICK SPINOUS PROCESS. THE PHYSICIAN REPORTEDLY DID NOT USE EXCESSIVE FORCE DURING DEPLOYMENT BUT WAS NOT PERFORMING THE SAGITTAL WIGGLE TECHNIQUE AS HE WAS SUPPOSED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390404 ↗
• MalfunctionOct 27, 2025Difficult to Open or Close; Material Integrity Problem; Material Twisted/Bent; Difficult to Open or Close; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE DURING DEPLOYMENT. DURING DEPLOYMENT THE PHYSICIAN HEARD A POPPING SOUND AND NOTICED THAT THE SPACER WAS NO LONGER OPENING. THE PROCEDURE WAS HALTED AND THE SPACER WAS REMOVED, IT WAS REVEALED THAT THE CAP ON TOP OF THE SPACER WAS BROKEN AND BENT BACK. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING DEPLOYMENT. THE BROKEN SPACER WAS REMOVED AND A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389935 ↗
• MalfunctionOct 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE DURING DEPLOYMENT. THE CAP ON THE TOP OF THE SPACERS POPPED OFF WHEN THE SPACER WAS 80 PERCENT DEPLOYED. THE PATIENT'S FACET JOINTS WERE DESCRIBED AS VERY ARTHRITIC. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING DEPLOYMENT. THE BROKEN SPACER WAS REMOVED AND A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389920 ↗
• MalfunctionOct 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE UPON DEPLOYMENT DURING AN IMPLANT PROCEDURE. THE INTENDED IMPLANT SITE WAS NOTED TO BE TIGHT, WITH THICK BONE AND SCAR TISSUE CONTRIBUTING TO RESISTANCE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW, SMALLER IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381853 ↗
• MalfunctionOct 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING DEPLOYMENT. THE BROKEN SPACER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE PHYSICIAN NOTED NO THICK BONE OR OBSTRUCTIONS IN THE PATIENTS ANATOMY AND NO EXCESSIVE FORCE WAS USED DURING THE IMPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376050 ↗
• MalfunctionOct 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE SUPERION INDIRECT DECOMPRESSION SPACER CRACKED NEAR THE WELD DURING AN IMPLANT PROCEDURE. THE BROKEN SPACER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN NOTED THAT THE PRESENCE OF OSTEOPHYTES MAY HAVE CAUSED RESISTANCE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375620 ↗
• MalfunctionOct 23, 2025Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE. THE PHYSICIAN NEEDED TO UN-DEPLOY AND RE-DEPLOY A FEW TIMES DUE TO HITTING RESISTANCE AND FIND THE RIGHT SPACE. EVENTUALLY, THE SPACER STOPPED DEPLOYING. THE PHYSICIAN TOOK THE INSERTER OUT AND SAW THAT THE TOP OF THE SPACER WAS DETACHED FROM THE IMPLANT BODY. THE PHYSICIAN DID NOT USE EXCESSIVE FORCE DURING THE PROCEDURE. THE BROKEN SPACER/PIECES WERE REMOVED AND A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373231 ↗
• MalfunctionOct 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING DEPLOYMENT. THE BROKEN SPACER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE PHYSICIAN NOTED THE PATIENT ANATOMY ONLY PROVIDED A TIGHT SPACE FOR IMPLANT; THE PRESENCE OF OSTEOPHYTES MAY HAVE CAUSED RESISTANCE; AND THAT NO EXCESSIVE FORCE WAS USED DURING THE IMPLANT PROCEDURE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350658 ↗
• MalfunctionOct 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUPERION INDIRECT DECOMPRESSION SPACER BROKE DURING AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE PATIENT APPEARED TO HAVE SOME OSTEOPHYTES, AND THE IMPLANT BROKE WHILE ATTEMPTING TO DEPLOY THE IMPLANT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343330 ↗
• MalfunctionOct 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SPACER BROKE DURING THE IMPLANT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW IMPLANT. THE DEVICE WAS DISCARDED AND WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343059 ↗

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