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	Migration (4003); Lack of Effect (4065)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• 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: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 25650388
• Report Number: 3006630150-2026-04473
• Device Sequence Number: 12228945
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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): 09/22/2026

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: 40106796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 09/13/2023
• 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: 66 YR
• Patient Sex: Female