MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

Initial communication received from the patient about this event included the physician's name (no contact information).However, the event did not include patient identifier, specific information about the implant (size and lot number), exact implant date, nor additional information that would allow for proper communication with the surgeon.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 prior to this report.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 third-party patient market survey where the subject initially reported a "bone infection" and the implant having receding into the bone after an implant procedure performed on (b)(6) 2017.The patient followed up on her report via medwatch report mw5086849, where they added an episode of sesamoiditis.No exact implant date or clinical assessment was made available.

• 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 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543814
• MDR Report Key: 8695688
• MDR Text Key: 147891054
• Report Number: 3009351194-2019-00005
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

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: 05/16/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention