MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-8MM

Device Problem Failure to Seal (4070)

Patient Problems Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Hernia (2240)

Event Date 04/07/2022

Event Type  Injury  

Event Description

Patient reported extreme pain during follow-up appointment 12 days after initial implantation.Imaging done showed there was a recurrent disc herniation around the barricaid implant.During revision surgery the doctor used a burr to remove about 3mm inferiorly and superiorly of the lamina and removed about 10% of the facet joint to increase access to the defect area.The nerve was identified and manipulated out of the way.The herniated material was removed and according to the doctor notes, "it was a recurrent disk herniation, or that is what it certainly felt like." the sample was sent to pathology but some of the material was obviously scar tissue and chunks of disc around the scar tissue pocket.Surgeon continued with a discectomy and closed the patient.19 days after revision surgery during a follow-up visit the notes showed the surgery site to have gram-positive rods directly around the barricaid implant.The patient was treated with 4 weeks of ancef.

Manufacturer Narrative

Scar tissue is a risk of every discectomy including with barricaid and without barricaid device.The barricaid device is labeled with the risks of scar tissue.Reports of scar tissue have not shown any increases beyond expected rates.Reherniation is an inherent risk of the barricaid device and it is labeled as such.The rates of reherniation have not increased beyond what is expected.The device batch records show the implant used was sterilized, and the type of sterilization would have been able to kill off any traces of gram positive bacteria.There have been no other complaints for infection from this lot therefore intrinsic does not believe our device was the source of this infection.

• 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 ; 7819320252
• MDR Report Key: 16601477
• MDR Text Key: 311926816
• Report Number: 3006232063-2023-00007
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA88MM0
• UDI-Public: M906BARA88MM0
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 08162101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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