MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A8-10MM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The imaging provided to intrinsic was performed at 8 month follow up and shows the mesh had migrated out of the disc space.The barricaid implant was partially removed to make room for the tlif during the surgical intervention.The removed components were sent to a 3rd party laboratory for analysis, and those results have not been communicated to intrinsic at the date of this report.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
The surgeon reported to intrinsic that a fusion (tlif) was performed on this patient 3.8 years (estimated) after implantation.The patient reported symptomatic back pain at 8 months post operation and within 3 months of that report the symptoms were intermittent, and the patient decided to wait it out to see if it improved.

• 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: 20261644
• Report Number: 3006232063-2024-00036
• Device Sequence Number: 15633968
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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: 06/19/2023
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 06112002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2020
• 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 Sex: Unknown