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

Model Number 101-9812

Device Problems Difficult to Open or Close (2921); Material Integrity Problem (2978)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression spacer implant procedure, the spindle cap had broken off the implant after a few deployment applications.The physician attempted to open the spacer using the sagittal arc technique and the implant was properly connected to the inserter.The patients anatomy formed a tight space which contributed to the physician having difficulty opening the implant.The broken implant was removed and replaced with a smaller sized implant.There were no patient complications postoperatively.

Manufacturer Narrative

Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.This damage indicates that excessive force was likely used.Additionally, the damage signifies the break was due to deployment against resistance, such as bone, and/or manipulation of the position of the device by shifting the inserter.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Device breakage can occur when used with forced deployment and is noted within the ifu as a potential complication associated with use of the device.

Event Description

It was reported that during an indirect decompression spacer implant procedure, the spindle cap had broken off the implant after a few deployment applications.The physician attempted to open the spacer using the sagittal arc technique and the implant was properly connected to the inserter.The patients anatomy formed a tight space which contributed to the physician having difficulty opening the implant.The broken implant was removed and replaced with a smaller sized implant.There were no patient complications postoperatively.

• 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: 15848682
• MDR Text Key: 306892405
• Report Number: 3006630150-2022-06458
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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,Followup
• Report Date: 01/09/2023

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: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29547992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Race: Black Or African American