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

Model Number 101-9812

Device Problems Material Integrity Problem (2978); Device Fell (4014)

Patient Problems Hematoma (1884); Paralysis (1997)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

It was reported that during an indirect decompression spacer implant procedure, the physician was unable to successfully implant the spacer between the fourth and fifth lumbar vertebral level.The company representative was present for the procedure and had expressed multiple times to the physician that the implant appeared to be deeper than the targeted position in the patients anatomy via x-ray imaging.Despite this, the physician assessed that the patients anatomy was not conducive to a successful implant of the spacer and therefore decided to remove the spacer.Removal was difficult because the spacer had already been deployed ventral to the lamina and the physician had to remove tissue and ligament to reach the device.Additionally, the spindle cap had broken during the procedure.After the implant was removed, it was accidentally dropped on the operating room floor.The device will not be returned as it was disposed by the medical facility.A new implant was opened and used to continue the procedure.Postoperatively, the patient experienced neurological deficits wherein the patient was unable to move her legs.Magnetic resonance imaging (mri) confirmed an epidural hematoma around the fourth and fifth lumbar vertebral level.The physician assessed that the cause of the neurological deficits was due to the hematoma and the hematoma was likely due to the traumatic removal of the implant that was placed too ventrally.The patient was hospitalized and underwent an emergency surgery to make repairs to the affected area.The patient was then placed in spinal cord rehabilitation.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16045249
• MDR Text Key: 306895715
• Report Number: 3006630150-2022-07264
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29850085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Race: Black Or African American