Model Number 3186 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/16/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event and patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
Related manufacturer reference number: 1627487-2020-23474, 1627487-2020-23475.It was reported the patient¿s system was explanted one week after implant.Reason for explant and date is unknown.
|
|
Manufacturer Narrative
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|