MAUDE Adverse Event Report: CARTIVA CARTIVA SCI; CARTIVA SYNTHETIC CARTILAGE PROSTHESIS

Model Number CAR-10-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/03/2017

Event Type  Injury  

Event Description

Failed cartiva synthetic cartilage implant per md.Possible foreign body reaction.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SYNTHETIC CARTILAGE PROSTHESIS
• Manufacturer (Section D): CARTIVA
• MDR Report Key: 7049312
• MDR Text Key: 92776227
• Report Number: MW5073479
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2017

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: Health Professional
• Device Model Number: CAR-10-US
• Device Lot Number: F042717002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1