MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	400921-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient got a barricaid implanted, he reherniated afterwards and on (b)(6) 2022 the patient had the barricaid implant successfully removed, and the surgeon put a tlif in its place.
Additional Manufacturer Narrative
Patient reherniated within 3 weeks of implantation.The barricaid device was removed to make room for a tlif to occur, the device was discarded so it was not able to be analyzed for any potential defects.Images showed the device in proper position and the surgeon did not note anything that points to a barricaid device failure.

• 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: 15769965
• Report Number: 3006232063-2022-00042
• Device Sequence Number: 12417555
• Product Code: QES
• UDI-Device Identifier: M906BARREMOVAL0
• UDI-Public: M906BARREMOVAL0
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2022

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: 01/31/2023
• Device Model Number: 400921-A
• Device Catalogue Number: R400921-A
• Device Lot Number: 01282002
• 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: 10/26/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male