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

Model Number 101-9810

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

The returned spacer was analyzed and revealed that a cam-lobe was significantly bent, and a severe abrasion was observed on the mating surface of the actuator as well as damage to the spindle.This damage indicates that the user exerted excessive force while attempting to deploy the implant against a rigid obstruction such as the spinous process.A product labeling review identified that the device was used per the instructions for use ifu product label.Additionally, it states do not force deployment or implant breakage or damage to bony structures may result, and if resistance is encountered, or if device position is suboptimal, completely close the implant before repositioning and redeployment.

Event Description

It was reported that during a superion indirect decompression system implant procedure while the physician was attempting to deploy the implant, about halfway through he took ap images and realized the top left lobe of the implant was bent.He closed the implant and was able to successfully remove it.As he attempted to open the second implant, he lost resistance and when he pulled the driver out, the tip of the implant was broken.He was able to remove the implant and broken piece from the driver, which broke off into the implant making it unusable.The broken implant was replaced with a new one and the procedure was completed successfully.

• 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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18022629
• MDR Text Key: 327737763
• Report Number: 3006630150-2023-06590
• 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: 10/27/2023

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: 40010128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• 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 Sex: Female