MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

The removed device was returned, and an assessment of the implant was performed.The articulating surface of the device exhibited scuffing and a small flap of material.The device's diameter and height were found to be within the post-sterilization ranges established through validation.The implant size was initially identified as a car-10-us device, however, the size of the device returned was within the 8 mm specification.This is likely due to the physician performing the removal not being the same as the implanting surgeon.The catalog and lot numbers for the involved device were not made available.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.Likewise, no additional information regarding this event was made available.As a result, no further 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

Feedback received from surgeon via their sales representative.According to the information received, a patient underwent removal of a cartiva device on (b)(6) 2019, approximately one year postoperative.The implant was initially described as a car-10-us.However, the lot number was not made available.Likewise, the exact date of implant, reason for removal, post-removal revision or additional details regarding the patient's clinical course or present condition were not made available.

• 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: 9135934
• MDR Text Key: 161934381
• Report Number: 3009351194-2019-00024
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/30/2019
• 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