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

Model Number 101-9812

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression spacer implant procedure, the physician attempted the sagittal wiggle applications after which the spindle cap eventually broke.It was assessed that the implant was not properly connected to the inserter and the physician did not deploy the implant enough to reposition the implant above the lamina.The broken implant was removed from the patient and a different spacer of the same size was used to complete the procedure successfully with no patient complications.

Event Description

It was reported that during an indirect decompression spacer implant procedure, the physician attempted the sagittal wiggle applications after which the spindle cap eventually broke.It was assessed that the implant was not properly connected to the inserter and the physician did not deploy the implant enough to reposition the implant above the lamina.The broken implant was removed from the patient and a different spacer of the same size was used to complete the procedure successfully with no patient complications.

Manufacturer Narrative

Device analysis performed on the returned indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.Damage to the device prevented functional testing.However, this damage to the spacer indicates 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.Additionally, 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.

• 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: 16423664
• MDR Text Key: 310047357
• Report Number: 3006630150-2023-00777
• 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: 03/30/2023

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: 29985233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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: Male
• Patient Race: Black Or African American