Device Problem
Fracture (1260)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Udi number: ni.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 revision surgery was performed to address a rod, which broke post-operatively.No further details are available.
|
|
Manufacturer Narrative
|
Additional information: results and conclusions - the device was not returned for evaluation so no results are available and no conclusions can be drawn.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.
|
|
Event Description
|
It was reported that a revision surgery was performed to address a rod which broke post-operatively.No further details are available.
|
|
Search Alerts/Recalls
|