MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Material Fragmentation (1261)

Patient Problem Reaction (2414)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

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 such as the exact implant date, additional details regarding the alleged reaction, and the patient's clinical course were made available.Therefore, no 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

According to the information received from the involved surgeon, a patient underwent a cartiva device removal approximately one year postoperatively.The exact date of implant is currently unknown.According to the physician's report, the implant exhibited subsidence and signs of apparent fragmentation at the time of explant, and, the patient was suspect of having exhibited a possible synovial/capsular reaction of undetermined origin at an unspecified time.No additional information regarding the product and patient clinical course was made available.

• Brand Name: CARTIVA SCI
• Type of Device: CARTIVA SCI
• Manufacturer (Section D): CARTIVA, INC.; 6120 windward parkway; suite 220; alpharetta GA 30022
• Manufacturer (Section G): CARTIVA, INC.; 1005 alderman drive; suite 208; alpharetta GA 30005
• Manufacturer Contact: tanya eberle ; 6120 windward parkway; suite 220; alpharetta 30005 ; 7707543814
• MDR Report Key: 9083098
• MDR Text Key: 161925439
• Report Number: 3009351194-2019-00016
• 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: 09/18/2019

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: 08/19/2019
• Initial Date FDA Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71 YR