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 Vertebral Fracture (4520)

Event Date 04/26/2021

Event Type  Injury  

Event Description

It was reported that during six month protocol imaging for the superion indirect decompression system clinical patient, the imaging showed spinous process fracture.There was no adverse event reported, and no further action is required.The device remains implanted in the patient.

Event Description

It was reported that during six month protocol imaging for the superion indirect decompression system clinical patient, the imaging showed spinous process fracture.There was no adverse event reported, and no further action is required.The device remains implanted in the patient.Additional information was received that the patient had complained of neck pain and was administered injections.The patient also experienced thigh pain, hip numbness and back pain.Therefore, the patient was referred to a neurosurgeon for a laminectomy, however, upon follow up the patient reported he felt good and no longer experienced back or leg pain and did not undergo laminectomy surgery.

Event Description

It was reported that during six month protocol imaging for the superion indirect decompression system clinical patient, the imaging showed spinous process fracture.There was no adverse event reported, and no further action is required.The device remains implanted in the patient.Additional information was received that the patient had complained of neck pain and was administered injections.The patient was also experiencing thigh pain, hip numbness and back pain and the patient was referred to a neurosurgeon for a possible laminectomy.Upon follow up the patient reported that he felt good as he was no longer experiencing back or leg pain and asked to hold off on surgery.There is no further course of action.Additional information was received that the patient had complained of neck pain and was administered injections.The patient also experienced thigh pain, hip numbness and back pain.Therefore, the patient was referred to a neurosurgeon for a laminectomy, however, upon follow up the patient reported he felt good and no longer experienced back or leg pain and did not undergo laminectomy surgery.Additional information was received that imaging performed showed the presence of healed spinous process fracture in the lumbar 4-5 level.

Event Description

It was reported that during six month protocol imaging for the superion indirect decompression system clinical patient, the imaging showed spinous process fracture.There was no adverse event reported, and no further action is required.The device remains implanted in the patient.Additional information was received that the patient had complained of neck pain and was administered injections.The patient was also experiencing thigh pain, hip numbness and back pain and the patient was referred to a neurosurgeon for a possible laminectomy.Upon follow up the patient reported that he felt good as he was no longer experiencing back or leg pain and asked to hold off on surgery.There is no further course of action.Additional information was received that imaging performed showed the presence of healed spinous process fracture in the lumbar 4-5 level.Additional information was received that the event was assessed as possibly device or procedure related.

Manufacturer Narrative

Update to block b5.

Event Description

It was reported that during six month protocol imaging for the superion indirect decompression system clinical patient, the imaging showed spinous process fracture.There was no adverse event reported, and no further action is required.The device remains implanted in the patient.Additional information was received that the patient had complained of neck pain and was administered injections.The patient was also experiencing thigh pain, hip numbness and back pain and the patient was referred to a neurosurgeon for a possible laminectomy.Upon follow up the patient reported that he felt good as he was no longer experiencing back or leg pain and asked to hold off on surgery.There is no further course of action.Additional information was received that imaging performed showed the presence of healed spinous process fracture in the lumbar 4-5 level.Additional information was received that the event was assessed as possibly device or procedure related.Additional information was received that upon further review, there is no spinous process fracture detected.

• 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: 12290383
• MDR Text Key: 265486333
• Report Number: 3006630150-2021-04336
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 700082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Male