MAUDE Adverse Event Report: INTRINSIC THERAPEUTICS BARRICAID ANNULAR CLOSURE DEVICE

Model Number 2730815-A8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Post Operative Wound Infection (2446)

Event Date 02/27/2020

Event Type  Injury  

Event Description

Patient was admitted to the hospital for a second time after worsening symptoms (was admitted first time for wound revision/infection few weeks ago).After mr scan done on (b)(6) 2020, (and initial diagnosis of discitis), the patient was scheduled for immediate revision/implant removal.Intra-op diagnosis was epidural abscess.

Manufacturer Narrative

The device was collected with some disc material, placed in formalin and sealed.Exponent inc., the retrieval analysis lab, received the device and has performed the physical analysis of the device.The device has been found to be intact with incidental scratches on the anchor and fraying of the occlusion component.These are expected and considered normal in the event of device removal.Tissue was also sent to the hospital's internal labs.Intrinsic has requested these reports on five (5) occasions but has not received them.Per intrinsic's risk analysis (failure mode and effects analysis - fmea), infection is an anticipated hazard that has been mitigated through manufacturing process controls and sterilization validations.A review of the manufacturing lot history file and sterilization records revealed no nonconformances and demonstrated that the device was manufactured to its specifications.

Event Description

Intra-op fluoro scans confirmed unchanged implant positioning (comparing with implantation day) and intraoperatively; physician confirmed no signs of disc material / reherniation or device migration.Device removal uneventful (device came out in a single piece, using extractor).Post op-fluoro confirms clean extraction, without any metal residues left behind.

• Brand Name: BARRICAID ANNULAR CLOSURE DEVICE
• Type of Device: BARRICAID
• Manufacturer (Section D): INTRINSIC THERAPEUTICS; 30 commerce way; ma
• MDR Report Key: 9881200
• MDR Text Key: 191267561
• Report Number: 3006232063-2020-00001
• Device Sequence Number: 1
• Product Code: QES
• Combination Product (y/n): N
• PMA/PMN Number: P160050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: 2730815-A8
• Device Lot Number: 04191901
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2020
• Device Age: 10 MO
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR