MAUDE Adverse Event Report: VERTIFLEX, INC. SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	100-9816
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Device analysis performed on the returned superion indirect decompression spacer revealed damage to the superior cam lobe driving tab.This damage prevented the actuator mating surface from properly engaging with the tabs that drive the cam lobes, causing the spacer to fail functional testing.The observed damage on the superior cam lobe driving tab was likely due to repeated deployment attempts, which jammed the actuator against the superior cam lobes and made it difficult to deploy the superior lobes.
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.
Additional Manufacturer Narrative
Correction to the initial mdr in block h6.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 damage to the superior cam lobe driving tab.This damage prevented the actuator mating surface from properly engaging with the tabs that drive the cam lobes, causing the spacer to fail functional testing.The observed damage on the superior cam lobe driving tab was likely due to repeated deployment attempts, which jammed the actuator against the superior cam lobes and made it difficult to deploy the superior lobes.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX, INC.; 2714 loker ave. west; suite 100; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23433247
• Report Number: 3006630150-2025-09845
• Device Sequence Number: 20029426
• Product Code: NQO
• UDI-Device Identifier: 00884662000307
• UDI-Public: (01)00884662000307
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 100-9816
• Device Catalogue Number: 100-9816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• 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
• 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