MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-10MM

Device Problem Failure to Seal (4070)

Patient Problem Hernia (2240)

Event Date 02/19/2024

Event Type  Injury  

Event Description

Intrinsic became aware on 30-jan-2024 that a patient implanted with a 10mm barricaid implant on (b)(6) 2020 had suffered a possible reherniation and was being treated conservatively.Intrinsic later became aware on 19-feb-2024 of a reoperation where surgical intervention was performed (tlif).The reoperation notes and images for this case showed the mesh had migrated posteriorly and there were end plate changes observed in l5 vertebral body.

Manufacturer Narrative

The occlusion component (mesh) portion of the device was removed and sent to a 3rd party for analysis and the results are still outstanding.If any laboratory results change the understanding of this case a follow-up will be submitted as required.

• 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
• MDR Report Key: 18886536
• MDR Text Key: 337448929
• Report Number: 3006232063-2024-00004
• 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: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2022
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 12061902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention