Catalog Number 07.02000.076 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problem
Inadequate Osseointegration (2646)
|
Event Date 01/19/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
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.Reference reports 3012447612-2023-00037 through 3012447612-2023-00039.
|
|
Event Description
|
It was reported that a revision surgery was performed to create more arthrodesis around some timberline cages because three screws were loose.The screws were removed and replaced.This is report two of three for this event.
|
|
Event Description
|
It was reported, that a revision surgery was performed.To create more arthrodesis around some timberline cages, because three screws were loose.The screws were removed and replaced.This is report two of three for this event.
|
|
Manufacturer Narrative
|
H6: additional method code: 4110.Additional information in h6: component, investigation type, findings and conclusions.Device evaluation: the device was not returned.And no photos were provided.So an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined, with the information provided.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: the lot number was not provided.So, the dhr was unable to be reviewed.Device usage: 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.
|
|
Search Alerts/Recalls
|