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	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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 implant and bony anatomy, such as the lamina or a hypertrophic spinous process, or suggest suboptimal implant positioning.
Additional Manufacturer Narrative
A retroactive review of events within the quality system identified this record as requiring remediation, including reporting and submission of an initial emdr per applicable criteria.Boston scientific has opened a corrective and preventive action (capa 8647) investigation to determine the root cause for why an initial emdr was not previously submitted to the fda in accordance with boston scientific established mdr reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to determine root cause and implement appropriate preventive action(s), as necessary.
Event or Problem Description
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.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.
Additional Manufacturer Narrative
Correction to the initial mdr in block b5.A retroactive review of events within the quality system identified this record as requiring remediation, including reporting and submission of an initial emdr per applicable criteria.Boston scientific has opened a corrective and preventive action (capa 8647) investigation to determine the root cause for why an initial emdr was not previously submitted to the fda in accordance with boston scientific established mdr reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to determine root cause and implement appropriate preventive action(s), as necessary.

• 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: 23432623
• Report Number: 3006630150-2025-09835
• Device Sequence Number: 8870141
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: (01)00884662000550(17)280911(10)40106796
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 40106796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 70 YR
• Patient Sex: Male