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

Model Number 101-9812

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced their pain symptoms returning four months after the implant procedure.The physician sent the patient for imaging and found that the screw and spindle cap of the indirect decompression (id) spacer had partially backed out of the device while still in between l3-4 lumbar vertebrae.The patient underwent an explant procedure to replace the spacer.The procedure was completed successfully.

Event Description

It was reported that the patient experienced their pain symptoms returning four months after the implant procedure.The physician sent the patient for imaging and found that the screw and spindle cap of the indirect decompression (id) spacer had partially backed out of the device while still in between l3-4 lumbar vertebrae.The patient underwent an explant procedure to replace the spacer.The procedure was completed successfully.

Manufacturer Narrative

The spacer was returned and the analysis of the field imaging (x-ray) revealed that the implant dislodged while still in between l3-4 lumbar vertebrae.The dislodgement of the implant is a known risk of the device.However, the analysis confirmed that the spindle cap was completely sheared off from the implant body and deformed.The actuator of the implant exhibited severed abrasion on the mating surface and a severe scrape on the side of the actuator.Therefore, functional testing could not be performed.The damage to the implant suggested that excessive force was used during the implantation of the device.A product labeling review identified that the device was used per the instructions for use (ifu)/product label, which states that migration or dislodgement of the implant from the original position, so that it becomes ineffective or causes damage to adjacent bone or soft tissues, including nerves, and loosening, fatigue, deformation, breakage or disassembly of the implant, which may require another operation to remove the implant, and may require another method of treatment are known risks associated with the use of lumbar spine implants and associated instruments.The ifu also states not to force deployment or implant breakage or damage to bony structures, avoid application of excessive stress on instrumentation, and should any resistance be encountered during deployment of the implant, it may be suggestive of interference between the implant and bony anatomy (e.G., lamina, hypertrophic spinous process), and/or suboptimal implant positioning.Additionally, if resistance is encountered, or if device position is suboptimal, completely reverse-deploy or close the implant before repositioning and redeployment.

• 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: 15928602
• MDR Text Key: 304954360
• Report Number: 3006630150-2022-06776
• 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
• Report Date: 01/09/2023

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: 28627392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Race: Black Or African American