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

Model Number 101-9810

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

It was reported that the spacer was properly deployed into the inner spinous space during an implant procedure.However, the resistance on the driver was lost and caused the spindle cap to be separated from the spacer.The spacer was removed and the procedure was rescheduled due to the physicians concern about the patient responsiveness to additional medication and anesthesia.

Event Description

It was reported that the spacer was properly deployed into the inner spinous space during an implant procedure.However, the resistance on the driver was lost and caused the spindle cap to be separated from the spacer.The spacer was removed and the procedure was rescheduled due to the physicians concern about the patient responsiveness to additional medication and anesthesia.Additional information was received that the patient was rescheduled for implant under general anesthesia.The procedure was completed successfully with a level 2 implantation.

Manufacturer Narrative

Device analysis performed on the returned superion indirect decompression spacer revealed that the spindle cap was completely sheared off from the implant body.The detachment of the spindle cap was due to excessive force.This damage to the spacer indicates the break was due to both the deployment against resistance, such as bone, and not correctly attaching the inserter to the spacer.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 the 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): VERTIFLEX INC; 2714 loker ave west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12921728
• MDR Text Key: 281651475
• Report Number: 3006630150-2021-06895
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: 01/13/2022

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: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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