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

Model Number 101-9814

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

Patient Problem Pain (1994)

Event Date 03/02/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing pain and ineffective therapy.The patient underwent an explant procedure.

Event Description

It was reported that the patient was experiencing pain and ineffective therapy.The patient underwent an explant procedure.

Manufacturer Narrative

Visual inspection of the returned superion indirect decompression spacer, 101-9814 (800153), revealed that the actuator was misaligned within the implant body resulting in severe damage to the implant body and severely stripped screw thread.The damage to the implant was sufficient to prevent functional testing and is believed 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, pain and discomfort associated with the operative site or presence of implants and failure of the device or procedure to improve symptoms and or function are noted within the ifu as a potential complications associated with the use of the device.Based on all available information, boston scientific engineers concluded that, per the labeling review, the reported events of pain and ineffective therapy are known inherent risks of the device.The damage to the implant body, observed by visual inspection, is believed to have occurred during the explant procedure due to an unintended use error.

• 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; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13795230
• MDR Text Key: 287328172
• Report Number: 3006630150-2022-01063
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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 Sex: Male