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

Model Number 101-9812

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Nerve Damage (1979); Pain (1994); Movement Disorder (4412)

Event Date 10/19/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced constant extreme new pain in their right thigh and groin areas.The patient stated that it has severely limited their ability to walk, bend, sleep, use the toilet, drive, lift light objects, and decreased their mobility in general.The patient experienced a sharp pain in their right thigh and then their right groin area after the first spacer implant procedure for the l4-l5 lumbar vertebrae.The patient stated that it seemed that the spacer had pushed the l4 lumbar vertebrae into the l4-l3 lumbar vertebrae space and was pressing on a nerve.The physician offered to treat the patient with steroids, but the patient declined.The patient went to the emergency room to treat the pain since there were times that the patient could not walk at all.A computed tomography (ct) scan was performed and the patient was advised to contact their surgeon.However, the patient stated that they did not hear back from his surgeon.The patient reported that they were also taking over 2000 mg of ibuprofen daily for the pain.The patient stated that they were mobile and active prior to the first spacer implant procedure.The patient underwent a second spacer implant procedure to add a second spacer.However, the patient stated that they still have severe groin pain and are still taking over 2000 mg of ibuprofen daily for the pain.

Event Description

It was reported that the patient experienced constant extreme new pain in their right thigh and groin areas.The patient stated that it has severely limited their ability to walk, bend, sleep, use the toilet, drive, lift light objects, and decreased their mobility in general.The patient experienced a sharp pain in their right thigh and then their right groin area after the first spacer implant procedure for the l4-l5 lumbar vertebrae.The patient stated that it seemed that the spacer had pushed the l4 lumbar vertebrae into the l4-l3 lumbar vertebrae space and was pressing on a nerve.The physician offered to treat the patient with steroids, but the patient declined.The patient went to the emergency room to treat the pain since there were times that the patient could not walk at all.A computed tomography (ct) scan was performed and the patient was advised to contact their surgeon.However, the patient stated that they did not hear back from his surgeon.The patient reported that they were also taking over 2000 mg of ibuprofen daily for the pain.The patient stated that they were mobile and active prior to the first spacer implant procedure.The patient underwent a second spacer implant procedure to add a second spacer.However, the patient stated that they still have severe groin pain and are still taking over 2000 mg of ibuprofen daily for the pain.Additional information was received that no migration occurred.The patient still has groin pain but states that he is seeing improvement.

• 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 CA ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13162749
• MDR Text Key: 283244698
• Report Number: 3006630150-2021-07466
• Device Sequence Number: 1
• Product Code: NQO
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 27783072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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): Other