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 02/22/2023

Event Type  malfunction  

Event Description

It was reported that the physician noted that the patient had thick bone while applying the sagittal wiggle during the implant procedure of the superion indirect decompression (id) spacer.The physician heard the spindle cap pop, and the id spacer would no longer deploy.The id spacer was replaced with a smaller device and successfully implanted.Imaging taken in the field confirmed proper placement of the device and patient did well post-operatively.

Manufacturer Narrative

Analysis of the returned superion indirect decompression (id) spacer revealed that the spindle cap was completely sheared off from the implant body in addition to a severe abrasion on the mating surface of the actuator and tool damage to the spindle.The damage to the implant indicates failure was likely due to deployment again resistance and/or manipulation of the position of the device by gear shifting of the inserter.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, labeling states to not force deployment or implant breakage or damage to bony structures may result.Therefore, boston scientific concludes the probable cause of the reported event was unintended use error caused or contributed to event.

Event Description

It was reported that the physician noted that the patient had thick bone while applying the sagittal wiggle during the implant procedure of the superion indirect decompression (id) spacer.The physician heard the spindle cap pop, and the id spacer would no longer deploy.The id spacer was replaced with a smaller device and successfully implanted.Imaging taken in the field confirmed proper placement of the device and patient did well post-operatively.

• 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: 16600584
• MDR Text Key: 312282418
• Report Number: 3006630150-2023-01501
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• 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: 29985232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Race: White