Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Implant Pain (4561)
|
Event Date 11/20/2023 |
Event Type
Injury
|
Event Description
|
Related manufacturer report number: 1627487-2023-05833.It was reported that the patient experienced discomfort at the cervical anchor site.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein the patient's anchors were moved slightly laterally away from spinous process to address the issue.
|
|
Manufacturer Narrative
|
Date of event is estimated.
|
|
Manufacturer Narrative
|
The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
|
|
Search Alerts/Recalls
|