MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

The reported event did not include patient or physician identifier, specific information about the implant (size and lot number), nor additional information that would allow for proper communication with the surgeon or the patient.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

Feedback received via medwatch report mw5086959.No initial reporter information was made available.According to the information received, the individual reported "revision to approved implant that was significantly damaged and had decreased in size since initial implantation" and "increased bony channel for the implant".According to the report, the device was implanted on (b)(6) 2018, following removal and revision (b)(6) 2019 (approximately 10 months postoperatively).No product catalog number or lot number, physician contact information, description of device damage, or patient clinical assessment, including revision performed, were 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 GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543814
• MDR Report Key: 8780152
• MDR Text Key: 150685337
• Report Number: 3009351194-2019-00008
• 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
• Type of Report: Initial
• Report Date: 07/11/2019

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: 06/11/2019
• Initial Date FDA Received: 07/11/2019
• 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