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

Model Number	101-9816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain in their back and leg areas caused by the spacer.The patient underwent an explant procedure where the spacer was removed.
Event or Problem Description
It was reported that the patient was experiencing pain in their back and leg areas caused by the spacer.The patient underwent an explant procedure where the spacer was removed.
Additional Manufacturer Narrative
The returned spacer was analyzed and visual inspection revealed a stripped thread on the actuator.The spacer deployed with minor resistance due to the stripped thread on the actuator.With all the available information, boston scientific concludes the reported event of the patient experiencing pain caused by the spacer implant was not confirmed.Pain associated with the spacer is a known inherent risk of the device.However, visual inspection revealed a stripped thread on the actuator.The spacer did not function acceptably due to deploying with minor resistance due to the stripped thread on the actuator.The cause is unintended use error contributed to the event as the damage is to believed to have occurred during the explant procedure due to excessive force.The damage is not related to device malfunction.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11601684
• Report Number: 3006630150-2021-01324
• Device Sequence Number: 3291532
• Product Code: NQO
• UDI-Device Identifier: 00884662000567
• UDI-Public: 00884662000567
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/09/2023
• Device Model Number: 101-9816
• Device Catalogue Number: 101-9816
• Device Lot Number: 800048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR