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

Model Number 101-9810

Device Problem Migration (4003)

Patient Problems Vertebral Fracture (4520); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  Injury  

Event Description

It was reported that sixteen days post-implant, the patient's indirection decompression spacer had migrated.Imaging was performed which confirmed the migration.No further action was taken, and the device remains implanted.It was also reported that the patient experienced a fracture of their posterior spinous process at lumbar 4-5.The fracture was assessed as not related to the device, procedure or disease progression.The migration of the spacer was assessed as related to the spinous process fracture.

Event Description

It was reported that sixteen days post-implant, the study patient's indirection decompression spacer had migrated.Imaging was performed which confirmed the migration.No further action was taken, and the device remains implanted.It was also reported that the patient experienced a fracture of their posterior spinous process at lumbar 4-5.The fracture was assessed as not related to the device, procedure or disease progression.The migration of the spacer was assessed as related to the spinous process fracture.Additional information was received that the fracture was causally related to the device, and not related to the procedure or disease progression.During the six-month imaging, it still showed a presence of fracture.

Event Description

It was reported that sixteen days post-implant, the study patient's indirection decompression spacer had migrated.Imaging was performed which confirmed the migration.No further action was taken, and the device remains implanted.It was also reported that the patient experienced a fracture of their posterior spinous process at lumbar 4-5.The fracture was assessed as not related to the device, procedure or disease progression.The migration of the spacer was assessed as related to the spinous process fracture.Additional information was received that the fracture was causally related to the device, and not related to the procedure or disease progression.During the six-month imaging, it still showed a presence of fracture.

Event Description

It was reported that sixteen days post-implant, the study patient's indirection decompression spacer had migrated.Imaging was performed which confirmed the migration.No further action was taken, and the device remains implanted.It was also reported that the patient experienced a fracture of their posterior spinous process at lumbar 4-5.The fracture was assessed as not related to the device, procedure or disease progression.The migration of the spacer was assessed as related to the spinous process fracture.Additional information was received that the fracture was causally related to the device, and not related to the procedure or disease progression.During the six-month imaging, it still showed a presence of fracture.Additional information was received that an x-ray report revealed no evidence of a fracture.

Event Description

It was reported that sixteen days post-implant, the study patient's indirection decompression spacer had migrated.Imaging was performed which confirmed the migration.No further action was taken, and the device remains implanted.It was also reported that the patient experienced a fracture of their posterior spinous process at lumbar 4-5.The fracture was assessed as not related to the device, procedure or disease progression.The migration of the spacer was assessed as related to the spinous process fracture.Additional information was received that the fracture was causally related to the device, and not related to the procedure or disease progression.During the six-month imaging, it still showed a presence of fracture.Additional information was received that an x-ray report revealed no evidence of a fracture.Additional information was received that an x-ray report imaging was indeterminate.Another x-ray imaging showed some evidence of healing.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16565070
• MDR Text Key: 311692527
• Report Number: 3006630150-2023-01331
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/27/2023; 07/27/2023; 11/03/2023; 01/26/2024
• Supplement Dates FDA Received: 05/23/2023; 08/18/2023; 12/01/2023; 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 81 YR
• Patient Sex: Female