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 Problem Pain (1994)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient's indirect decompression spacer implant had migrated and the patient experienced an increase in pre-existing pain in the low back and legs.Device migration was confirmed via x-ray imaging.The physician assessed that the device migration was due to the patient doing too much physical activity too soon after the implant procedure.Therefore, the patient underwent a revision procedure where the spacer was explanted and successfully replaced with a larger spacer.The patient was doing well post-operatively.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Device analysis performed on the returned indirect decompression spacer revealed no anomalies.However, a product labeling review identified that migration of the implant and new or worsened back or leg pain are known inherent risks with the use of lumbar spine implants.Additionally, the instructions for use (ifu) advises to avoid strenuous activity during the post-operative period.

Event Description

It was reported that the patients indirect decompression spacer implant had migrated and the patient experienced an increase in pre-existing pain in the low back and legs.Device migration was confirmed via x-ray imaging.The physician assessed that the device migration was due to the patient doing too much physical activity too soon after the implant procedure.Therefore, the patient underwent a revision procedure where the spacer was explanted and successfully replaced with a larger spacer.The patient was doing well post-operatively.

• 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: 14350462
• MDR Text Key: 291400343
• Report Number: 3006630150-2022-02160
• 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: 06/13/2022

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: 28460943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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
• Patient Age: 84 YR
• Patient Race: White