MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The patient was contacted to request additional information about this event, such as the exact implant and removal dates, the involved surgeon's name and contact information, and product information (if known).The patient declined.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.Likewise, the involved physician could not be contacted to receive his expert opinion in regards to this event, therefore 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

Fda medwatch patient report (mw5087964) received.According to the information provided, the reporter received a cartiva implant in 2019.The exact implant date was not provided.Following, the patient underwent removal and revision to fusion at a later day the same year as they claimed "continued pain, difficulty ambulating", and, electromagnetic images showing "subsidence, the return of bone spurs, and a fracture in the foot.".The exact date of removal was not provided.Likewise, no additional information such as surgeon's name and contact information or product information 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 GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta 30005 ; 7707543814
• MDR Report Key: 8915663
• MDR Text Key: 155047594
• Report Number: 3009351194-2019-00015
• 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: consumer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention