MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

The medwatch report did not include the product catalog and lot number involved in this event.In addition, contact information for the reporter or involved surgeon for 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.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 (mw5088745).According to the information provided, the subject received a revision of an implant that was "significantly damaged" and had "decreased in size since initial implantation", along with "increase bony channel for the implant".The implant date provided is (b)(6) 2019; explant date is (b)(6) 2019.The patient did not provide their contact information, involved surgeon name or contact information, nor product catalog and lot number.

• 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,
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543814
• MDR Report Key: 9097565
• MDR Text Key: 164578467
• Report Number: 3009351194-2019-00018
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 08/22/2019
• 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): Hospitalization; Required Intervention