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

Model Number 101-9812

Device Problem Migration (4003)

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

Event Date 03/08/2022

Event Type  Injury  

Event Description

It was reported that during a superion indirect decompression system clinical trial that the implant had migrated.X-ray imaging performed confirmed implant migration.Clinical investigators report this device deficiency did not lead to adverse event, nor were there any medical or surgical interventions required.

Event Description

It was reported that during a superion indirect decompression system clinical trial that the implant had migrated.X-ray imaging performed confirmed implant migration.Clinical investigators report this device deficiency did not lead to adverse event, nor were there any intervention required.Boston scientific subsequently received information indicating imaging results showed the implant was displaced at the l4/l5 lumbar vertebra after a fracture of the l4 spinous process.

Event Description

It was reported that during a superion indirect decompression system clinical trial that the implant had migrated.X-ray imaging performed confirmed implant migration.Clinical investigators report this device deficiency did not lead to adverse event, nor were there any intervention required.Boston scientific subsequently received information indicating imaging results showed the implant was displaced at the l4/l5 lumbar vertebra after a fracture of the l4 spinous process.

Manufacturer Narrative

Correction to section h6 patient codes: added patient code 'vertebral fracture'.

Event Description

It was reported that during a superion indirect decompression system clinical trial that the implant had migrated.X-ray imaging performed confirmed implant migration.Clinical investigators report this device deficiency did not lead to adverse event, nor were there any intervention required.Boston scientific subsequently received information indicating imaging results showed the implant was displaced at the l4/l5 lumbar vertebra after a fracture of the l4 spinous process.Boston scientific subsequently received information indicating that the superion indirect decompression system implant was explanted.The patient was noted to be well post-operatively.

Event Description

It was reported that during a superion indirect decompression system clinical trial that the implant had migrated.X-ray imaging performed confirmed implant migration.Clinical investigators report this device deficiency did not lead to adverse event, nor were there any intervention required.Boston scientific subsequently received information indicating imaging results showed the implant was displaced at the l4/l5 lumbar vertebra after a fracture of the l4 spinous process.Boston scientific subsequently received information indicating that the superion indirect decompression system implant was explanted.The patient was noted to be well post-operatively.Boston scientific subsequently received information indicating that the adverse event of the spinous process fracture at l4-5 lumbar vertebra was reported as a causal relationship to the procedure and device, and unlikely caused by the progression of disease.The device was not returned to boston scientific as it was retained by the facility.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13941061
• MDR Text Key: 288130571
• Report Number: 3006630150-2022-01311
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• 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: 27735759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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): Required Intervention