MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

Device Problem Fracture (1260)

Patient Problems Pain (1994); Swelling (2091)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2018, it was reported that a (b)(6) man had undergone removal of a cartiva device.The surgeon indicated that at the time of removal the device was not fully intact.

Event Description

According to the information provided, the patient received a 10mm cartiva sci device on (b)(6) 2017 without issue.Following, it was reported that the patient experienced pain and swelling, with removal of the device occurring on (b)(6) 2018.

• 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: 7317793
• MDR Text Key: 101642182
• Report Number: 3009351194-2018-00002
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: (01)00852897002038(10)F072017001(17)2019-08-31
• 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: Physician
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2019
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F072017001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• 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
• Patient Age: 47 YR