MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number CAR-10-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Swelling (2356); Inadequate Pain Relief (2388)

Event Date 01/30/2017

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017, it was reported that a patient of unknown age was experiencing post-operative pain and swelling and presented to the clinical for assessment.The date of initial surgery is not known; however, the duration of implant was reported as "3 weeks".Upon return to the clinic, the physician decided to remove the implant and perform a revision to fusion.-.

Event Description

According to the information provided, the patient received a 10 mm cartiva sci device without issue.During the early post-operative course, the patient appeared to be recovering normally.At approximately 3 weeks post-operative, the patient presented with pain and significant swelling.

• 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: 6365065
• MDR Text Key: 68559232
• Report Number: 3009351194-2017-00001
• Device Sequence Number: 1
• Product Code: PNW
• UDI-Device Identifier: 00852897002038
• UDI-Public: (01)00852897002038(10)F090116002(17)2018-09-30
• 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: 02/27/2017

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: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: CAR-10-US
• Device Lot Number: F090116002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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