MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS, INC BARRICIAD ACD; BARRICAID

Model Number BAR-A8-8MM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Vertebral Fracture (4520)

Event Date 04/19/2022

Event Type  Injury  

Manufacturer Narrative

Device was not returned so investigation was limited to the communications with company representative who was present during the procedure.It appears that the surgeon's technique caused the device to damage the adjacent s1 vertebral body.The device was extracted and no further harm to the patient occurred.Intrinsic is not aware of any defects during the manufacturing process that could have contributed to this condition.

Event Description

After the first 2 initial taps on the implant, the trajectory looked good but when the surgeon continued to mallet the implant the rest of the way in, it caught on the upper lip of the adjacent vertebral body, bunched up and remained in the canal.This tension during the final malleting loosened the implant and the implant caused some skiving off of the s1 plate.

• Brand Name: BARRICIAD 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 ; 7819320222
• MDR Report Key: 15868436
• MDR Text Key: 304334844
• Report Number: 3006232063-2022-00015
• Device Sequence Number: 1
• Product Code: QES
• UDI-Device Identifier: M906BARA88MM0
• UDI-Public: M906BARA88MM0
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: BAR-A8-8MM
• Device Catalogue Number: 2730815-A8
• Device Lot Number: 08162101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2020
• 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