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 09/11/2023

Event Type  malfunction  

Event Description

It was reported that during a superion indirect decompression system (ids) implant procedure, during deployment the physician could not get the spacer to open fully and the implant came apart.The physician had to reposition the implant two more times to get the implant to line up properly, and on the third attempt was when the implant broke.It was noted that the physician did not use excessive force while deploying the spacer, and the implant was properly attached to the inserter prior to deployment.Another spacer was implanted without incident and the patient was doing well postoperatively.The spacer will not be returned as it was lost.

Manufacturer Narrative

Model 101-9812, lot 40027337: device analysis performed on the returned indirect decompression spacer revealed that the reported complaint of the spindle cap breaking was confirmed.Visual revealed that the spindle cap was completely sheared off from the implant body and spindle found to be outside of the main body.The damage to the implant was sufficient to prevent functional testing.In addition, visual examination of the returned implant also revealed that a cam-lobe was significantly bent.This damage suggests that the user exerted excessive force while attempting to deploy the implant against a rigid obstruction (spinous process).

Event Description

It was reported that during a superion indirect decompression system (ids) implant procedure, during deployment the physician could not get the spacer to open fully and the implant came apart.The physician had to reposition the implant two more times to get the implant to line up properly, and on the third attempt was when the implant broke.It was noted that the physician did not use excessive force while deploying the spacer, and the implant was properly attached to the inserter prior to deployment.Another spacer was implanted without incident and the patient was doing well postoperatively.The spacer will not be returned as it was lost.

• 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: 17804192
• MDR Text Key: 324127079
• Report Number: 3006630150-2023-05790
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 40027337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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: 69 YR