Superion™ 101-9808Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884662000529), received between Oct 15, 2025 and Oct 31, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 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 WERE OBSERVED ON ONE OF THE CAM LOBES. HOWEVER, THE IMPLANT FUNCTIONED ACCEPTABLY DURING THE FUNCTIONAL TEST. 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 23441610 ↗
• 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 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 23432745 ↗
• 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 23432240 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SUPERION IMPLANT PROCEDURE, THE SPACER BROKE INTO PIECES DURING DEPLOYMENT. THE BROKEN SPACER WAS REMOVED AND A NEW SPACER WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN IS BELIEVED TO HAVE USED EXCESSIVE FORCE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280924 ↗

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