MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 08/18/2019

Event Type  Injury  

Manufacturer Narrative

The product catalog and lot number of the device involved in this event 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, the device could not be evaluated as it remains implanted.The involved surgeon was contacted to request additional information, and their clinical perspective, in regards to this event.The physician contacted the headquarters via telephone on (b)(6) 2019.In their reply, the physician stated that the surgery procedure took place without issue, and the wound healed well.During the healing process, a small, superficial cellulitis event did occur.The skin infection was treated and healed with antibiotics after a few days.As for the patient, the subject has been recovering as expected, walking and resuming daily activities.The physician also reported that the magnetic resonance imaging procedure performed on the patient had confirmed osteoarthritis.Furthermore, the surgeon expressly stated that, at the present time, there is no dislodgement of the device, no bone infection had occurred, and, "there is nothing wrong with the device".If additional information about this event is received in the future, this report will be updated as needed.

Event Description

Feedback received from a patient.According to the information provided, the subject suffered continued pain and swelling approximately one week following implant surgery, for which they were treated with antibiotics.Following, the patient underwent magnetic resonance imaging procedures- both with and without contrast- resulting in a bone infection diagnosis on (b)(6) 2019.The product catalog and lot numbers for the involved device 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: pablo mercado ; 6120 windward parkway; suite 220; alpharetta, GA 30005 ; 7707543853
• MDR Report Key: 9384588
• MDR Text Key: 168573708
• Report Number: 3009351194-2019-00027
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• PMA/PMN Number: P150017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

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
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 59 YR
• Patient Weight: 107