MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA SCI

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 it was reported that a (b)(6) patient of unknown age was experiencing post-operative discomfort and had presented to the clinical for assessment.The date of initial surgery, duration of implant, concomitant procedures, and post-operative course are unknown and the us medical professional reporting the event did not implant the device originally (implanted in canada) and does not have access to the original implant surgical post-operative records.Removal of the device by the us surgeon was reportedly without complication and was accomplished with ease with the removing surgeon indicating a k-wire was not needed for removal.

Event Description

(b)(6) patient reported discomfort associated with the implant that had been placed during a prior surgery outside of the us (date of implant, duration of implant unknown, concomitant procedures performed and the implanting post-op course are unknown).

• 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: 5938888
• MDR Text Key: 54288746
• Report Number: 3009351194-2016-00001
• 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: 07/13/2016

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention