MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICAID ACD

Model Number BAR-A8-10MM

Device Problem Fracture (1260)

Patient Problem Nerve Damage (1979)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

The surgeon and proctor narrative does not suggest that there were any technique related issues with the use of the device.A lot history review was performed, and nothing alluded to a conclusion to why this occurred.The device was discarded and not returned for review, so there was no detailed analysis of the the device that fractured.

Event Description

Per surgicloud notes: "nitinol wire snapped at base of implant tool.Dr.(b)(6) believe(sic) the snapped wire hit dura and caused dural tear which had to be repaired with dura seal and suture due to tear" the removal tool was used to remove the partially implanted anchor from the vertebra.

• 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
• MDR Report Key: 17541964
• MDR Text Key: 321091281
• Report Number: 3006232063-2023-00025
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA810MM0
• UDI-Public: M906BARA810MM0
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BAR-A8-10MM
• Device Catalogue Number: 2731015-A8
• Device Lot Number: 04302120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other