MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA; PROSTHESIS, TOE, HEMI, PHALANGEAL

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/03/2018

Event Type  Injury  

Event Description

Revision of approved implant that was significantly damaged and had decreased in size since initial implantation.Fda safety report id # (b)(4).

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, TOE, HEMI, PHALANGEAL
• Manufacturer (Section D): CARTIVA, INC.; alpharetta GA
• MDR Report Key: 8650607
• MDR Text Key: 146509685
• Report Number: MW5086956
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Disability
• Patient Age: 76 YR
• Patient Weight: 68