MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A8-8MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The use of the removal tool causes more than trivial damage to the vertebra.The description of the events detailed in this mdr represent intrinsic therapeutic's understanding at the time of submission.If any further information is found which would change or alter any conclusions or information another follow-up will be completed.Intrinsic therapeutics will continue to monitor for updates/trends.
Event or Problem Description
Attempted implantation on s1, and the mesh buckled.It looked like it got caught on the annulus.The implantation was stopped and a removal tool was used to explant, which worked without incidence.Unable to implant on l5 due to nerve location.

• 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: nicholas grow ; 30 commerce way; woburn, MA 01801 ; 7819320222
• MDR Report Key: 22108618
• Report Number: 3006232063-2025-00022
• Device Sequence Number: 8140601
• Product Code: QES
• UDI-Device Identifier: M906BARA88MM0
• UDI-Public: M906BARA88MM0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/29/2025

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: 11/04/2025
• Device Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 10282201
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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: Other
• Patient Sex: Unknown