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

Model Number	100-9812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was no longer receiving relief from the superion indirect decompression spacer (spacer).A flouroscopy showed that the device was well placed and there was no evidence of device failure or damage.The physician proceeded with explant.During the explant, the device was undeployed but due to bony overgrowth the spacer could not be removed.The spacer was redeployed and left in place and the incision was closed.
Event or Problem Description
It was reported that the patient was no longer receiving relief from the superion indirect decompression spacer (spacer).A fluoroscopy showed that the device was well placed and there was no evidence of device failure or damage.The physician proceeded with explant.During the explant, the device was undeployed but due to bony overgrowth the spacer could not be removed.The spacer was redeployed and left in place and the incision was closed.

• Brand Name: SUPERION INTERSPINOUS SPACER
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15374377
• Report Number: 3006630150-2022-04587
• Device Sequence Number: 5661362
• Product Code: NQO
• UDI-Device Identifier: 00884662000260
• UDI-Public: 00884662000260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/30/2023
• Device Model Number: 100-9812
• Device Catalogue Number: 100-9812
• Device Lot Number: 800017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White