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

Model Number 101-9814

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

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression spacer implant procedure, the physician observed that the patient had a large spinous process and bony growth.The physician placed the implant more posterior to avoid obstruction and used force when applying the sagittal wiggle to help deploy the implant.The physician had a difficult time opening the implant.An audible cracking noise was heard, and the spacer was removed.The spindle cap of the spacer had bent and broken off.There were no patient complications due to the event.A new spacer was successfully implanted, and the patient was doing well postoperatively.

Event Description

It was reported that during an indirect decompression spacer implant procedure, the physician observed that the patient had a large spinous process and bony growth.The physician placed the implant more posterior to avoid obstruction and used force when applying the sagittal wiggle to help deploy the implant.The physician had a difficult time opening the implant.An audible cracking noise was heard, and the spacer was removed.The spindle cap of the spacer had bent and broken off.There were no patient complications due to the event.A new spacer was successfully implanted, and the patient was doing well postoperatively.

Manufacturer Narrative

Analysis of the returned spacer revealed that the spindle cap was completely sheared off from the implant body due to excessive force.The damage to the implant was likely due to deployment against resistance (e.G., bone) and/or manipulation of the position of the device by gear shifting of the inserter thus unintended use error caused or contributed to the event.

• 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 sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16034742
• MDR Text Key: 306895266
• Report Number: 3006630150-2022-07167
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 29539391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White