MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	101-9814
Medical Device Problem Codes	Difficult to Open or Close (2921); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, failure of the device/procedure to improve symptoms and/or function, pain and discomfort associated with the operative site or presence of implants, formation of scar tissue at implant site is noted within the ifu as a potential complication associated with the use of the device.A risk review performed for the superion indirect decompression system device confirmed that the event of lack of effect, failure to close, pain, scar tissue, surgical intervention, and absence of treatment is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the superion indirect decompression system device is acceptable.Based on the available information (and in the absence of device return), the root cause of the reported clinical observations cannot be established.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25201476
• Report Number: 3006630150-2026-03218
• Device Sequence Number: 10036264
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: (01)00884662000550(17)270602(10)29523354
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 29523354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2485-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male