MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10

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

Patient Problem Fungal Infection (2419)

Event Date 07/23/2017

Event Type  Injury  

Event Description

According to the information available, the patient was reported to have a blister and stiffness post-operative of placement of a 10 mm cartiva device for 1st mtp joint osteoarthritis.According to the report, the patient's blister began draining and the patient developed an infection at approximately 10 weeks post-operative.The patient underwent removal of the cartiva device and placement of an antibiotic cement spacer.

Event Description

The testing report was requested, but not provided to the manufacturer.The verbal communication relayed a.Terreus organism, a rare organism known to present in immune compromised individuals as a primary infection of the lung due to inhalation of spores with secondary presentations related to hematogenous seeding.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkway; suite 220; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC.; 1005 alderman drive; suite 208; alpharetta GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; atlanta, GA 30005 ; 7707543800
• MDR Report Key: 6817538
• MDR Text Key: 83517131
• Report Number: 3009351194-2017-00003
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: (01)00852897002038(10)F040617002(17)2019-04-30
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: CAR-10
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F040617002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/27/2017
• 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