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

Model Number	101-9812
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted with a superion implant experienced a lack of therapy from the device, as their recurrent lateral recess stenosis symptoms in the legs had returned.The patient underwent a surgical procedure to explant the device, but the explant was not successful.The physician then chose to implant a non-bsc device instead, which resolved the patient's leg symptoms.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in may 2025.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred in may 2025.
Event or Problem Description
It was reported that a patient implanted with a superion implant experienced a lack of therapy from the device, as their recurrent lateral recess stenosis symptoms in the legs had returned.The patient underwent a surgical procedure to explant the device, but the explant was not successful.The physician then chose to implant a non-bsc device instead, which resolved the patient's leg symptoms.Additional information was received that the patient's superion spacer was explanted on (b)(6) 2025.The patient is doing well post operatively.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks h7 and h9.The device was returned to boston scientific for analysis and passed all tests performed.The device was completely intact and exhibited normal device characteristics.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 is noted within the ifu as a potential complication associated with the use of the device.A risk review performed for the superion implant device confirmed that the event of lack of effect; no clinical signs, symptoms or conditions; therapeutic response decreased, surgical intervention, modified surgical procedure, additional device required, device explantation is a known event defined in the product 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 implant device is acceptable.Based on all known information, boston scientific could not confirm the allegation of lack of therapy from the device.The returned superion implant passed visual and functional testing.Therefore, the most probable conclusion is no problem detected.
Event or Problem Description
It was reported that a patient implanted with a superion implant experienced a lack of therapy from the device, as their recurrent lateral recess stenosis symptoms in the legs had returned.The patient underwent a surgical procedure to explant the device, but the explant was not successful.The physician then chose to implant a non-bsc device instead, which resolved the patient's leg symptoms.Additional information was received that the patient's superion spacer was explanted on (b)(6) 2025.The patient is doing well post operatively.

• 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: 23538722
• Report Number: 3006630150-2025-10351
• Device Sequence Number: 18585730
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: (01)00884662000543(17)270809(10)29927752
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 04/20/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29927752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/14/2025; 03/26/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/06/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White