MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-10MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Date 01/06/2022

Event Type  Injury  

Event Description

Patient presented with possible reherniation, and revision surgery was performed.During revision surgery, the barricaid device was found to be in proper position and performing appropriately.Device was not touched, no reherniation was found, no new defect in the disc was present.Scar tissue/adhesions were found compressing the nerve.

Manufacturer Narrative

Based on the surgeon narrative, it was confirmed that a surgical intervention was performed to decompress a nerve root that was causing pain.During the reoperation, the surgeon confirmed that: 1) scar tissue was compressing the nerve; 2) there was no herniated nuclear material nor new annular defect present; and 3) the barricaid was still appropriately positioned and intact.No link between the scar tissue and barricaid was established.Scar tissue may develop after a discectomy regardless of whether or not a barricaid is implanted.

• Brand Name: BARRICAID ACD
• Type of Device: BARRICAID
• Manufacturer (Section D): INTRINSIC THERAPEUTICS, INC; 30 commerce way; woburn MA 01801
• Manufacturer (Section G): INTRINSIC THERAPEUTICS, INC; 30 commerce way; woburn MA 01801
• Manufacturer Contact: rachael nelsen ; 30 commerce way; woburn, MA 01801 ; 7819320222
• MDR Report Key: 15878326
• MDR Text Key: 304442500
• Report Number: 3006232063-2022-00002
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160050
• 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
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 06152002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2020
• 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): Required Intervention