MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

The product catalog and lot number of the device involved in this event was not made available.As a result, a review of the quality and manufacturing records for the involved product lot could not be carried out.The physician did not provide additional patient information regarding their clinical course.Finally, the involved device was not available for evaluation.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

Feedback received from surgeon where they reported an implant removal.According to the information received, the implant "had fragmented with loose pieces being found in the joint".The physician reported a "significant foreign body reaction with cyril changes in phalanx/ erosions." the patient was described as "low demand." the implant and removal dates, product catalog and lot numbers, patient information, nor additional details on the subject's clinical course were made available.Likewise, the device, or photographic images, were not made available for assessment.

• 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 30022 ; 7707543814
• MDR Report Key: 9117113
• MDR Text Key: 165409961
• Report Number: 3009351194-2019-00020
• 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

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: 08/26/2019
• Initial Date FDA Received: 09/25/2019
• 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