MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI; CARTIVA SCI,

Model Number CAR-10

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

At the time of implant, the drill bit was inserted and the cavity was not fully drilled due to a small area of patient bone preventing the implant from sitting properly.The cavity was drilled additionally to remove any bone that might remain and the implant was seated proud.The patient underwent manipulation of the of the toe and the implant was noted to be proud at that time ((b)(6) 2017).A capsulotomy and release of the lateral ligaments was also carried out.After removal of the cartiva device, the tissue was noted to be with fibrosis and inflammation.At that time, the device appeared to have sunken into the cavity and was no longer proud.

Event Description

According to the information received on 1 nov 2017, the patient was reported to have experienced swelling and pain that did not resolve post-operative of receiving a 10 mm cartiva device for 1st mtp joint osteoarthritis.According to the report, the patient had a history of osteomyelitis and cheilectomy in the same joint.The cartiva implant at approximately 4 months post-operative.The surgeon reported that there did not appear to be any active issue other than the hallux rigidis at the time of removal.There was no hospitalization and no infection.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI,
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkwy, suite 22; alpharetta GA 30005
• Manufacturer (Section G): CARTIVA, INC.; 1005 alderman drive; suiet 208; alpharetta GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suie 220; atlanta, GA 30005 ; 7707543800
• MDR Report Key: 7076476
• MDR Text Key: 93555063
• Report Number: 3009351194-2017-00004
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: (01)00852897002038(10)F042717002(17)2019-05-31
• 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
• Report Date: 12/01/2017

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: 05/31/2019
• Device Model Number: CAR-10
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F042717002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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