MAUDE Adverse Event Report: CARTIVA, INC CARTIVA; PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT

Model Number CAR-10-AUS

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # car-10-us, p150017 was cleared in the united states.The product was not returned nor were images provided for review; therefore, product analysis cannot be performed.

Event Description

It was reported that the patient underwent a toe surgery.The patient underwent a revision surgery due to pain.Upon removal the implant was in good position however it was worn and indented.The patient had the toe fused with a plate.

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT
• Manufacturer (Section D): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer (Section G): CARTIVA, INC; 6120 windward parkway; suite 220; alpharetta, ga
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, tn
• MDR Report Key: 10304548
• MDR Text Key: 199840143
• Report Number: 3009351194-2020-00005
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: CAR-10-AUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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