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

Model Number	101-9812
Medical Device Problem Codes	Nonstandard Device (1420); 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	01/13/2020
Type of Reportable Event	Malfunction
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 of the returned superion indirect decompression spacer revealed that the implant failed functional testing.The cam lobes deployed in a non-uniform pattern, with a noticeable delay in the deployment of the superior cam lobe.Although the implant ultimately deployed completely and successfully, the superior cam lobe showed resistance to rotating freely around the pivot pin.Microscopic examination indicated damage to the actuator at its mating surface, along with evidence of spindle burnishing consistent with engagement by the driver.The representative confirmed the presence of dense bone, which may have led the user to apply excessive force during implantation.This suspicion is supported by the observed damage to the actuator and spindle, as repeated deployment attempts under such conditions can cause significant wear on the pivot pins, resulting in cam lobe malfunction.
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.
Event or Problem Description
Device analysis of the returned superion indirect decompression spacer revealed that the implant failed functional testing.The cam lobes deployed in a non-uniform pattern, with a noticeable delay in the deployment of the superior cam lobe.Although the implant ultimately deployed completely and successfully, the superior cam lobe showed resistance to rotating freely around the pivot pin.Microscopic examination indicated damage to the actuator at its mating surface, along with evidence of spindle burnishing consistent with engagement by the driver.The representative confirmed the presence of dense bone, which may have led the user to apply excessive force during implantation.This suspicion is supported by the observed damage to the actuator and spindle, as repeated deployment attempts under such conditions can cause significant wear on the pivot pins, resulting in cam lobe malfunction.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.

• 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): VERTIFLEX INC; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23433355
• Report Number: 3006630150-2025-09849
• Device Sequence Number: 12895082
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: (01)00884662000543(17)241014(10)800208
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/17/2025

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 Expiration Date: 10/14/2024
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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 Sex: Unknown