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

Model Number 101-9814

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 03/17/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain due to the placement of the superion indirect decompression spacer.The physician assessed that placement was overly posterior and the bone was growing around the spacer resulting in the patient's pain.The patient underwent a procedure to reposition the spacer at the level 4/5 vertebrae, but after three attempts to move the device and with the presence of large spinous processes, the cam lobes bent and the implant was replaced.The patient did well post-operatively.

• 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: 14018385
• MDR Text Key: 288651404
• Report Number: 3006630150-2022-01484
• 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
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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: 27707787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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