MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

A review of the relevant manufacturing records for the involved device lot indicates that all aspects of manufacture, from initial processing through packaging and sterilization met all quality criteria for final release.A review of the sterilization records noted no abnormalities and all processing was within the required specification.A review of the complaint records indicates that there are no other similar events reported to date involving cartiva device lot f040518001.Patient information, additional details surrounding the removal intervention and the reported event as described were not made available for investigation.As a result, a patient impact assessment could be performed.At the present time, the event could not be definitely confirmed.Should additional details be provided in the future, an update to this submission will be provided.

Event Description

Feedback received from implanting surgeon via their sales representative.According to the information received, a patient underwent a cartiva implant procedure on (b)(6)2018.Following, the implant was removed after an unspecified "injury to the foot" on (b)(6)2018, a month postoperative.The physician indicated to the sales representative that the device appeared "damaged" when it was removed.No additional information was 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: 8699451
• MDR Text Key: 148006243
• Report Number: 3009351194-2019-00006
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 008528972038
• UDI-Public: (01)008528972038(10)F040518001(17)20200430
• Combination Product (y/n): N
• 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: 06/14/2019

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: CAR-10-US
• Device Catalogue Number: CAR-10-US
• Device Lot Number: F040518001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2019
• 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