MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Material Fragmentation (1261)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

The medwatch report did not include the product catalog and lot number involved in this event.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.As the patient did not include their contact information, the alleged outcomes attributed to this event could not be confirmed.In addition, contact information for the involved surgeon for this event were not made available.As a result, the involved physician could not be contacted to receive their expert opinion in regards to this event.Finally, the involved device was not available for evaluation.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 (mw5088853).According to the information provided, the subject received a cartiva implant in their right mtp.The patient reported a staphylococcus infection occuring right after surgery, continued pain after 2 weeks postoperative, and, per the implanting physician, the device had broken, requiring a removal.The implant date provided is (b)(6) 2017; explant date is (b)(6) 2018.The patient did not provide their contact invormation, involved surgeon name or contact information, not 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 GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543814
• MDR Report Key: 9100236
• MDR Text Key: 163639402
• Report Number: 3009351194-2019-00019
• 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

• 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: 09/20/2019
• 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; Other; Required Intervention; Disability