MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/23/2018

Event Type  Injury  

Event Description

According to the information received through medwatch report #mw5075848, an un-identified patient with unknown clinical history received an mtp cartiva implant on (b)(6) 2017.Post-operatively, the joint showed slow improvement and the patient experienced inflammation and pain.Per the medwatch report, the device was removed at approximately 7 months ((b)(6) 2018) with bony erosion requiring the use of a bone graft.

• 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; alpharetta 30005 ; 7707543814
• MDR Report Key: 7468171
• MDR Text Key: 106725922
• Report Number: 3009351194-2018-00003
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/27/2018

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: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention