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

Model Number 101-9812

Device Problems Defective Device (2588); Migration (4003)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  Injury  

Event Description

It was reported that the patient felt the spinous process spacer migrate out of position while he was doing physical therapy.The patient underwent a revision procedure where the spacer was replaced.

Event Description

It was reported that the patient felt the spinous process spacer migrate out of position while he was doing physical therapy.The patient underwent a revision procedure where the spacer was replaced.

Manufacturer Narrative

The returned spacer was analyzed and revealed severely stripped thread on the actuator.This damage prevented performing the functional test.The damage suggests that the user likely exerted excessive force while attempting to remove the implant, therefore, it is believed that the damage is not related to a device malfunction or to device migration.Per the instructions for use, device migration is a known inherent risk with use of this 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; suite 100; valencia CA 91355
• MDR Report Key: 11311822
• MDR Text Key: 231304551
• Report Number: 3006630150-2021-00414
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention