Catalog Number 07.02010.001 |
Device Problem
Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/21/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
|
|
Event Description
|
It was reported that a closure top was still moving after final tightening while the surgeon was trying to compress the segment.There were no reported patient impacts.
|
|
Manufacturer Narrative
|
Device evaluation: product is not returning and photos were not provided, so device evaluation can not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to the surgical technique being used or other unknown factors.Dhr review: dhr could not be reviewed as lot numbers were not provided.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
|
|
Event Description
|
It was reported that a closure top was still moving after final tightening while the surgeon was trying to compress the segment.There were no reported patient impacts.
|
|
Search Alerts/Recalls
|