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 Problem Implant Pain (4561)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: date approximate.

Event Description

It was reported that the patient was experiencing discomfort at the site of their superion interspinous spacer.In addition, the patient noted a return of stenosis symptoms after falling at least two times.The patient underwent a revision-removal procedure, however the physician was unable to remove the spacer after numerous attempts.The patient was then referred to a non-bsc spine surgeon, and the patient underwent a successful explant procedure.The surgeon assessed that there was a fracture, very likely from the falls the patient experienced, on the lumbar 4 spinous process.The patient was doing fine post operatively.The explanted device was discarded at the facility.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13031662
• MDR Text Key: 282483061
• Report Number: 3006630150-2021-07133
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• 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
• Patient Sex: Male