MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS BARRICAID; 12 MM BARRICAID

Model Number 2731015-EU

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

A complete manufacturing records review conducted by intrinsic showed that the product was manufactured to specification.The provided ct imaging showed clear evidence of the anchor head fracture.Based on the immediate post-operative image, the barricaid device was well-implanted.A comparison of the immediate post-op image and the image with the fractured anchor shows a marked decrease in posterior disc height.This decrease in disc height likely brought the opposing endplate in contact with the anchor head, providing the driving force for the eventual fracture.Anchor fracture is a known inherent risk identified in the device ifu with occurrence rates lower than those stated in our device ifu which are determined and based upon the pivotal superiority study.

Event Description

Male patient with a primary lumbar disc herniation at 4/5 left side underwent disc surgery on (b)(6) 2016, including barricaid implantation.A couple days later, he was discharged from the hospital, almost free of symptoms.(b)(4) therapy ended on (b)(6).Patient returned in (b)(6) 2017 with increasing leg and back pain.Conservative treatment led to significant improvement patient was active again.Same patient returned in (b)(6) 2019 with severe back and leg pain including paraesthesia without neurological malfunction.Reoperation was performed on (b)(6) 2019 to retrieve the fractured portion of the device.Surgery time: 1h35min.Some extensive scarring apart from those just normal parameters.Anchor head was found first mesh second, detached from the anchor head.

• Brand Name: BARRICAID
• Type of Device: 12 MM BARRICAID
• Manufacturer (Section D): INTRINSIC THERAPEUTICS; 30 commerce way; woburn,
• Manufacturer Contact: samir paliwal ; 30 commerce way; woburn, ma ; 9320222171
• MDR Report Key: 10394024
• MDR Text Key: 228353408
• Report Number: 3006232063-2019-00009
• Device Sequence Number: 1
• Product Code: QES
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2019
• Device Model Number: 2731015-EU
• Device Catalogue Number: BAR-D8-10X14
• Device Lot Number: 01251602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: 44 MO
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2017
• 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