MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number	BAR-A8-10MM
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon inserting the barricaid implant and noticed the mesh starting to buckle.The surgeon then removed the failed implant with mesh buckling and attempted a second implantation using the same damaged implant.The buckled mesh then contineud to buckle and it detached from the anchor.Then the surgeon removed the now separated mesh and sunk the implant further into the vertebral body.Anchor remains implanted and the patient was closed up.
Additional Manufacturer Narrative
Surgeon was interviewed after the surgery, and they agreed that they were using an angle that was too steep for the initial insertion.The surgeon was instructed when the buckling was noticed, to replace the damaged implant and was offered a new implant by the intrinsic representative present at the time of the operation.They decided to continue with using the damaged implant which caused it to fail by having the mesh barrier (seal) to detach from the anchor.This failure of the device was due to improper technique initially and continuing to use a damaged implant.There was no patient harm associated with this adverse event.

• 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: rachael nelsen ; 30 commerce way; woburn, MA 01801 ; 7819320222
• MDR Report Key: 15833355
• Report Number: 3006232063-2022-00022
• Device Sequence Number: 5391666
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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: 05/21/2024
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 04302120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Unknown