MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body Reaction (1868)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

A review of the quality and manufacturing records for the product lot was conducted and found that the product met all the predefined acceptance criteria for final release.All sterilization records demonstrate the appropriate dose was applied, and all sterilization specifications were met.As the implant cannot be returned, an assessment of the device could not be carried out.Of note: allegation of foreign body reaction was not received at the time of initiation of this file.This information was received on 23-jul-2019.Unfortunately, this detail was inadvertently and unintentionally overlooked until final review on (b)(6) 2019.As a result, the surgeon was immediately contacted via fax that day, (b)(6) 2019 and (b)(6) 2019 to request information about this event, to no avail.Based on the information provided by the patient, and no reporting from the involved surgeon, no confirmation nor definitive root cause could be determined for this event.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 where they reported receiving a cartiva implant on (b)(6) 2018 that has subsided and may require removal and revision.The patient later claimed to have suffered a foreign body reaction.

• 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: pablo mercado ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543853
• MDR Report Key: 9329171
• MDR Text Key: 166742312
• Report Number: 3009351194-2019-00026
• 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: Other
• Type of Report: Initial
• Report Date: 11/15/2019

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
• Device Expiration Date: 03/31/2020
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F022218002
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 11/15/2019
• 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
• Patient Age: 58 YR