MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A8-8MM
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Failure to Seal (4070)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Vertebral Fracture (4520)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The trauma the patient experienced caused the device to migrate and fracture the endplate that held it in place.The original implant position was also deeper than the surgical technique manual describes.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
A patient fell and suffered a traumatic event at the index level of a barricaid implant.On (b)(6) 2025, a surgery was scheduled and performed.During the revision surgery, the surgeon exposed the device and removed the new additional herniation and also discovered and removed part of a fractured vertebral endplate."the barricaid device was found to be stable after probing.The surgeon stated the mesh portion of the device, "was wedged between the two endplates."therapies for bone fracture(s) were adminstered and the patient was closed.

• 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: 22108043
• Report Number: 3006232063-2025-00021
• Device Sequence Number: 12563240
• Product Code: QES
• UDI-Device Identifier: M906BARA88MM0
• UDI-Public: M906BARA88MM0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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 Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 10102402
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown