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

Model Number 101-9810

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); No Code Available (3191)

Event Date 11/11/2020

Event Type  Injury  

Event Description

It was reported that the patient was recently implanted with the spacer and experienced numbness going down their right leg the next morning.The physician assessed that the numbness was caused by a large disc protrusion.The patient went to the emergency room and underwent an explant procedure to remove the spacer.The explanted device was disposed by the facility.

Event Description

It was reported that the patient was recently implanted with the spacer and experienced numbness going down the right leg the next morning.The physician assessed that the numbness was caused by a large disc protrusion.The patient went to the emergency room and underwent an explant procedure to remove the spacer.The explanted device was disposed by the facility.

Event Description

It was reported that the patient was recently implanted with the spacer and experienced numbness going down the right leg the next morning.The physician assessed that the numbness was caused by a large disc protrusion.The patient went to the emergency room and underwent an explant procedure to remove the spacer.The explanted device was disposed by the facility.

Manufacturer Narrative

Correction to block a1: patient identifier and g2: report source.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; 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: 10951743
• MDR Text Key: 219849050
• Report Number: 3006630150-2020-06028
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 700068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention