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

Model Number 101-9810

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 07/16/2020

Event Type  malfunction  

Event Description

It was reported that during the superion implant procedure the spacer cap broke due to the patients extremely tight spaced anatomy at l3-l4 level of the spine.The physician was able to carefully maneuver through the patients very short spinous process to remove the broken spacer and replace it with a smaller implant.The device was discarded at the facility and was not returned.

• 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; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12241450
• MDR Text Key: 264081207
• Report Number: 3006630150-2021-04134
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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