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 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant.Upn: 101-9810.Model: superion ids 10mm.Serial: n/a.Batch: 29360264.Product family: superion implant.Upn: 101-9810.Model: superion ids 10mm.Serial: n/a.Batch: 29360264.

Event Description

It was reported that during the superion indirect decompression system implant procedure as the physician was deploying the implant when reaching approximately 45% the implanter would disengage, and the implant could not be opened any further.The implant was removed, and it was observed that the spindle cap had broken.A second attempt to implant a device was utilized, upon deployment the implanter disengaged at approximately 45% and implant broke at the spindle cap.A third device was utilized with the same results.The procedure was then aborted.It was also noted that there may have been thick bone, osteophytes, or other obstructions causing resistance.This report is for the first device.

Event Description

It was reported that during the superion indirect decompression system implant procedure as the physician was deploying the implant when reaching approximately 45% the implanter would disengage, and the implant could not be opened any further.The implant was removed, and it was observed that the spindle cap had broken.A second attempt to implant a device was utilized, upon deployment the implanter disengaged at approximately 45% and implant broke at the spindle cap.A third device was utilized with the same results.The procedure was then aborted.It was also noted that there may have been thick bone, osteophytes, or other obstructions causing resistance.This report is for the first device.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant.Upn: 101-9810.Model: superion ids 10mm.Serial: n/a.Batch: 29360264.Product family: superion implant.Upn: 101-9810.Model: superion ids 10mm.Serial: n/a.Batch: 29360264.Analysis of the returned indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body.The damage to the implant indicates failure was due to a combination of deployment against resistance and physician failing to correctly attach the inserter to the spacer.A labelling review was performed, and it did not reveal any anomalies.Additionally, device breakage can occur when used with forced deployment and is noted within the instructions for use (ifu) as a potential complication associated with the use of the device.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant, upn: 101-9810, model: superion ids 10mm, serial: n/a, batch: 29360264.Product family: superion implant, upn: 101-9810, model: superion ids 10mm, serial: n/a, batch: 29360264.Analysis of the returned indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body.The damage to the implant indicates failure was due to a combination of deployment against resistance and physician failing to correctly attach the inserter to the spacer.A labelling review was performed, and it did not reveal any anomalies.Additionally, device breakage can occur when used with forced deployment and is noted within the instructions for use (ifu) as a potential complication associated with the use of the device.

Event Description

It was reported that during the superion indirect decompression system implant procedure as the physician was deploying the implant when reaching approximately 45% the implanter would disengage, and the implant could not be opened any further.The implant was removed, and it was observed that the spindle cap had broken.A second attempt to implant a device was utilized, upon deployment the implanter disengaged at approximately 45% and implant broke at the spindle cap.A third device was utilized with the same results.The procedure was then aborted.It was also noted that there may have been thick bone, osteophytes, or other obstructions causing resistance.This report is for the first 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: 15498771
• MDR Text Key: 304871047
• Report Number: 3006630150-2022-05073
• 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,Followup
• Report Date: 02/22/2023

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: 29540069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 01/13/2023; 02/10/2023
• Supplement Dates FDA Received: 02/07/2023; 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White