Catalog Number SN2023-0-23507 |
Device Problem
Fracture (1260)
|
Patient Problem
No Code Available (3191)
|
Event Date 05/12/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
This device is similar to those cleared by k111301.There was not a death or serious injury associated with this event.This malfunction has not been previously reported on this or a similar device and is not likely to lead to a death or serious injury if it were to recur.Therefore, this event is not reportable.Reference report 3003853072-2018-00047.
|
|
Event Description
|
It was reported that a revision surgery was performed to remove and replace two screws which were broken post-operatively.There were no reported patient impacts associated with the revision surgery.This is report one of two for this event.
|
|
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.
|
|
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.
|
|
Manufacturer Narrative
|
The returned screw was evaluated.The screw shaft was found to have fractured.The cause cannot be determined with the available information.A review of the manufacturing records did not find any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper use and also listed implant fracture as a possible side effect of using the device.
|
|
Event Description
|
It was reported that a revision surgery was performed to remove and replace two screws which were broken post-operatively.There were no reported patient impacts associated with the revision surgery.This is report one of two for this event.
|
|
Search Alerts/Recalls
|