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

Model Number	101-9816
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
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.Device analysis confirmed the complaint.Visual inspection found that the implant had suffered significant damage.The pivot pin on the superior cam lobe was broken, which resulted in it's disengagement from the implant body.The damage to the implant indicates failure due to subjecting the implant to excessive stress (i.E.Malleating).Therefore, product analysis confirmed that the most probable cause of the complaint is unintended use error caused or contributed to event.Additionally, a labeling review was completed and reveal no anomalies.The instructions for use (ifu) states after implant deployment, the implant should be driven ventrally by removing the driver and gently tapping on the inserter.
Event or Problem Description
It was reported that during a superion implant procedure, the spacer broke.After fully deploying the implant the physician went to mallet the implant when the superior cam lobes broke off in a backwards direction, fully separating from the body of the implant.The physician removed the cannula and used grasping rasps to retrieve both the upper lobe section and the rest of the implant.A new spacer was used to complete the procedure successfully.
Additional Manufacturer Narrative
Correction to the initial mdr in block h11.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.Device analysis confirmed the complaint.Visual inspection found that the implant had suffered significant damage.The pivot pin on the superior cam lobe was broken, which resulted in its disengagement from the implant body.The damage to the implant indicates failure due to subjecting the implant to excessive stress (i.E.Malleating).Therefore, product analysis confirmed that 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 (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.
Event or Problem Description
It was reported that during a superion implant procedure, the spacer broke.After fully deploying the implant the physician went to mallet the implant when the superior cam lobes broke off in a backwards direction, fully separating from the body of the implant.The physician removed the cannula and used grasping rasps to retrieve both the upper lobe section and the rest of the implant.A new spacer was used to complete the procedure successfully.

• 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; carlsbad CA 92010
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23430224
• Report Number: 3006630150-2025-09787
• Device Sequence Number: 13211125
• Product Code: NQO
• UDI-Device Identifier: 00884662000567
• UDI-Public: (01)00884662000567(17)250212(10)800290
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• 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): 11/10/2025

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: 02/12/2025
• Device Model Number: 101-9816
• Device Catalogue Number: 101-9816
• Device Lot Number: 800290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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 Age: 72 YR
• Patient Sex: Unknown