MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A8-10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006232063-2022-00002
• Device Sequence Number: 11395941
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2022

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown