MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problems Material Fragmentation (1261); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

The product catalog and lot number of the device involved in this event were not made available.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.The patient did not provide contact information for the involved physicians.Therefore, additional patient information regarding their clinical course could not be received.Finally, the involved device was not available for evaluation.Hence, no investigation into this occurrence could be performed.If additional information is received in the future, this file will be re-opened for assessment/ investigation and updated accordingly.

Event Description

Feedback received from patient via medwatch report (mw5088744).According to the information received, the subject received a cartiva implant on (b)(6) 2019.The reason for the surgical procedure was unspecified.Approximately 6 to 8 months postoperative, the patient developed severe pain the in the operated area.Following, the subject visited with the involved podiatrist, where electromagnetic images exhibited signs of implant subsidence.The subject reported their orthopedic surgeon commenting that the implant had "fallen apart".The implant was removed and the patient was revised to fusion on (b)(6) 2019.The patient's contact information, product catalog and lot numbers, contact information for the involved physician, nor additional details regarding this event 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: 9118293
• MDR Text Key: 164331412
• Report Number: 3009351194-2019-00022
• 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: 09/24/2019

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
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/25/2019
• 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