MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the information provided by the involved surgeon on (b)(6) 2018, a cartiva implant appeared "fracture/sheared" when range motion movements were performed on a patient after implantation.The device was immediately removed and replaced with another cartiva device.The surgery was completed without further issue.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkway; suite 220; alpharetta 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: 7994696
• MDR Text Key: 124685464
• Report Number: 3009351194-2018-00008
• Device Sequence Number: 1
• Product Code: PNW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2018

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
• Device Expiration Date: 03/30/2020
• Device Model Number: CAR-10-US
• Device Lot Number: F030118001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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