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 Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 11/24/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort and pain.Migration was confirmed via x-ray and the physician assessed that the patient's pain came back due to the migration.The patient underwent a revision procedure and the spacer was explanted.The patient is doing well postoperatively and has fully recovered.The explanted device is expected to be returned for analysis.

Event Description

It was reported that the patient experienced discomfort and pain.Migration was confirmed via x-ray and the physician assessed that the patients pain came back due to the migration.The patient underwent a revision procedure and the spacer was explanted.The patient is doing well postoperatively and has fully recovered.Additional information was received that the patient had unusual or contraindicated anatomy.

Event Description

It was reported that the patient experienced discomfort and pain.Migration was confirmed via x-ray and the physician assessed that the patient's pain came back due to the migration.The patient underwent a revision procedure and the spacer was explanted.The patient is doing well postoperatively and has fully recovered.Additional information was received that the patient had unusual or contraindicated anatomy.

Manufacturer Narrative

The returned spacer was analyzed and the reported event of the patient experiencing discomfort and pain due to migration was confirmed.A visual inspection revealed that the spacer had tool marks and damaged threads.The damage was likely due to the explant procedure.However, it was reported that the implant had migrated and that the patient had unusual or contraindicated anatomy.A labelling review found that migration or dislodgement of the implant is a known risk associated with the use of lumbar spine implants and associated instruments.Therefore, with all the available information, the probable cause of the patients discomfort and pain was traced to intentional off-label, unapproved, or contraindicated use due to the patients unusual or contraindicated anatomy and migration, which is a known inherent risk with use of the device.

Event Description

It was reported that the patient experienced discomfort and pain.Migration was confirmed via x-ray and the physician assessed that the patient's pain came back due to the migration.The patient underwent a revision procedure and the spacer was explanted.The patient is doing well postoperatively and has fully recovered.Additional information was received that the patient had unusual or contraindicated anatomy.

Manufacturer Narrative

Correction to block a1: patient identifier.

Manufacturer Narrative

Device analysis was performed on the returned indirect decompression spacer and the reported event of the patient experiencing discomfort and pain due to migration could not be confirmed.A visual inspection revealed that the spacer had tool marks and damaged threads.The damage was likely due to the explant procedure.However, it was reported that the spacer had migrated and that the patient had unusual or contraindicated anatomy.A labeling review was performed and it did not reveal any anomalies.The instructions for use (ifu) states that risks associated with lumbar spine implants and associated instruments include inability of the device/procedure to improve symptoms and/or function, and migration or dislodgement of the spacer from the original position, so that it becomes ineffective.The ifu also states that the spacer is contraindicated in patients with spinal anatomy or disease that would prevent implantation of the device or cause the device to be unstable in situ, such as instability of the lumbar spine, e.G., isthmic spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1 to 4) and scoliosis.Based on all available information, the reported event of the patient experiencing discomfort and pain due to device migration could not be confirmed through device analysis.A visual inspection revealed that the spacer had tool marks and damaged threads, which was likely due to the explant procedure.In addition, it was reported that the spacer had migrated and that the patient had unusual or contraindicated anatomy.However, a labelling review was performed and found that migration or dislodgement of the spacer is a known risk associated with the use of lumbar spine implants and associated instruments.

Event Description

It was reported that the patient experienced discomfort and pain.Migration was confirmed via x-ray and the physician assessed that the patient's pain came back due to the migration.The patient underwent a revision procedure and the spacer was explanted.The patient is doing well postoperatively and has fully recovered.Additional information was received that the patient had unusual or contraindicated anatomy.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; suite 100; 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: 11024515
• MDR Text Key: 221996097
• Report Number: 3006630150-2020-06244
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: 11/01/2023

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 Expiration Date: 11/09/2023
• Device Model Number: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/08/2021; 03/09/2021; 12/21/2022; 10/06/2023
• Supplement Dates FDA Received: 02/04/2021; 04/06/2021; 01/17/2023; 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2018
• 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 Sex: Male