MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Swelling (2356); Post Operative Wound Infection (2446)

Event Date 04/13/2019

Event Type  Injury  

Manufacturer Narrative

Initial communication received from the patient about this event did not include specific information about the implant (size and lot number).Likewise, no contact information for the surgeon was provided.Product information, the surgeon's name and contact information, and details surrounding the reported event as described were not made available for investigation.As a result, a review of the quality and manufacturing records for the involved device (implant) lot could not be carried out, nor a patient impact assessment could be performed.At the present time, the event could not be definitely confirmed.Should additional details be provided in the future, an update to this submission will be provided.

Event Description

Patient feedback received via email communication where the subject reports continued pain, swelling, an alleged infection of undetermined cause or involvement, and limited toe mobility following an implant procedure performed on (b)(6) 2019.The patient reported that a follow-up procedure was scheduled for revision to fusion.

• 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, GA 30005 ; 7707543814
• MDR Report Key: 8607246
• MDR Text Key: 144940585
• Report Number: 3009351194-2019-00001
• 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: consumer
• Type of Report: Initial
• Report Date: 05/14/2019

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
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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