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

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 12/08/2017

Event Type  Injury  

Event Description

Revision of damaged/subsided implant with continued pain.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: 8650579
• MDR Text Key: 146511202
• Report Number: MW5086955
• 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: 60 YR
• Patient Weight: 54