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

Model Number 101-9812

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Vertebral Fracture (4520)

Event Date 03/22/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort and elected to have both spacers explanted.The patient underwent a revision procedure and both spacers were explanted.The physician noted that the patient had a l4 lumbar vertebrae spinous fracture.

Manufacturer Narrative

The spacer 101-9812 lot# 27594003 was returned and analyzed.A labeling review found that the reported event is a known risk associated with the use of lumbar spine implants and associated instruments.However, visual inspection revealed severe abrasion on the mating surface of the actuator, and the screw thread was stripped.Although, the implant functioned acceptably during the functional test.The damage is most likely to have occurred during the explant procedure.A product labeling review identified that the device was used per the instructions for use (ifu) product label.Additionally, the following are noted within the ifu as potential risks associated with the use of the device: discomfort and rehabilitation associated with recovery from surgery, pain and discomfort associated with the operative site or presence of implants, and fracture, damage or remodeling of adjacent anatomy, including bony structures or soft tissues during or after surgery.

Event Description

It was reported that the patient experienced discomfort and elected to have both spacers explanted.The patient underwent a revision procedure and both spacers were explanted.The physician noted that the patient had a l4 lumbar vertebrae spinous fracture.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14124867
• MDR Text Key: 289438168
• Report Number: 3006630150-2022-01694
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 27594003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male