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 Problem Fall (1848)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that although the physician had initially assessed that the patient was not a surgical candidate for the indirect decompression spacer, he later decided to proceed with implanting two spacers.The patient experienced a non-device related fall and dislodged the spacer that was implanted between the fifth lumbar vertebra and the first sacral vertebra.The physician assessed that the patients stenosis was severe, and chose to explant both devices and perform a endoscopic decompression with a competitors device.Due to the patients difficult anatomy, the physician was only able to explant the spacer that was between the fourth and fifth vertebrae, and the other spacer remained implanted.Mfg.Report 3006630150-2021-07401 for the device that remains implanted.There were no patient complications during the explant procedure.There will be no further course of action regarding the device that remains implanted in the patient.

Manufacturer Narrative

Device analysis performed on the returned indirect decompression spacer revealed the device had damage on the screw thread as well as severe abrasion on the mating surface of the actuator and on one of the wings of the inferior cam lobe.In addition, a functional test revealed there was slight resistance when deploying the spacer.It was assessed that this damage most likely occurred during the explant procedure.A product labeling review identified that the device was not used per instructions for use ifu as it states that the spacer is contraindicated in patients with spinal anatomy or disease that would cause the device to be unstable in situ.

Event Description

It was reported that although the physician had initially assessed that the patient was not a surgical candidate for the indirect decompression spacer, he later decided to proceed with implanting two spacers.The patient experienced a non-device related fall and dislodged the spacer that was implanted between the fifth lumbar vertebra and the first sacral vertebra.The physician assessed that the patients stenosis was severe, and chose to explant both devices and perform a endoscopic decompression with a competitors device.Due to the patients difficult anatomy, the physician was only able to explant the spacer that was between the fourth and fifth vertebrae, and the other spacer remained implanted.There were no patient complications during the explant procedure.There will be no further course of action regarding the device that remains implanted in the patient.

• 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; 2714 loker ave west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13126747
• MDR Text Key: 283140491
• Report Number: 3006630150-2021-07402
• 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,Followup
• Report Date: 02/09/2022

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: 800197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR
• Patient Sex: Female
• Patient Race: White