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

Model Number	101-9810
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
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.The device was returned for analysis, and the complaint was confirmed.Visual inspection showed that the spindle cap was completely sheared off the implant body.The damage was sufficient enough to preclude functional testing.The damage indicates failure was likely due to deployment against resistance (e.G., bone) and/or manipulation of the position of the device by gear shifting of the inserter.Based on the product analysis, the most probable cause of the complaint is unintended use error caused or contributed to event.Additionally, a labeling review was completed and revealed no anomalies.The instructions for use state that deployment should not be forced or implant breakage or damage to bony structures may result.Furthermore, if resistance to deployment is encountered, and repositioning of the implant is required, the driver should be rotated counterclockwise until a positive stop is reached and withdraw dorsally to collapse the cam lobes.
Event or Problem Description
It was reported that during a superion implant procedure, the spacer would not open, and the procedure had to be aborted.The patients anatomy was challenging as there was limited space in the spinous process.The physician did not use excessive force during the procedure.The broken spacer was removed.
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.The device was returned for analysis, and the complaint was confirmed.Visual inspection showed that the spindle cap was completely sheared off the implant body and was deformed.The damage was sufficient enough to preclude functional testing.The damage indicates failure was likely due to deployment against resistance (e.G., bone) and/or manipulation of the position of the device by gear shifting of the inserter.Based on the product analysis, the most probable cause of the complaint is unintended use error caused or contributed to event.Additionally, a labeling review was completed and revealed no anomalies.The instructions for use state that deployment should not be forced or implant breakage or damage to bony structures may result.Furthermore, if resistance to deployment is encountered, and repositioning of the implant is required, the driver should be rotated counterclockwise until a positive stop is reached and withdraw dorsally to collapse the cam lobes.
Event or Problem Description
It was reported that during a superion implant procedure, the spacer would not open, and the procedure had to be aborted.The patients anatomy was challenging as there was limited space in the spinous process.The physician did not use excessive force during the procedure.The broken spacer was removed.

• 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: 23431097
• Report Number: 3006630150-2025-09821
• Device Sequence Number: 8241949
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: (01)00884662000536(17)250605(10)800258
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/10/2025

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: 06/05/2025
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Race: White