Catalog Number 2000-9072 |
Device Problem
Fracture (1260)
|
Patient Problems
Ossification (1428); Foreign Body In Patient (2687)
|
Event Date 04/20/2022 |
Event Type
Injury
|
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.Reference report 3012447612-2022-00134.
|
|
Event Description
|
It was reported that two polaris 5.5 iliac screws were unable to be removed during a removal surgery after fusion was complete; the screws were strongly attached to the bone.While attempting to remove the first screw, the tip of the height adjuster broke off and became stuck in the screw shaft, preventing the removal of either piece.The tulip detached from the screw shaft while removing the second screw, so it also was unable to be fully removed.The surgeon does not anticipate further actions and the patient is in good condition.This is report three of three for this event.
|
|
Manufacturer Narrative
|
Corrections in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed that the tip of the device was fractured.Root cause: root cause was unable to be determined.This event could possibly be attributed to the bone growing around the screws and hardening to the point that the screw was unable to be removed.Dhr review: per dhr review, the dorsal height adjuster was likely conforming when it left zimvie control.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.
|
|
Event Description
|
It was reported that two polaris 5.5 iliac screws were unable to be removed during a removal surgery after fusion was complete; the screws were strongly attached to the bone.While attempting to remove the first screw, the tip of the height adjuster broke off and became stuck in the screw shaft, preventing the removal of either piece.The tulip detached from the screw shaft while removing the second screw, so it also was unable to be fully removed.The surgeon does not anticipate further actions and the patient is in good condition.This is report three of three for this event.
|
|
Search Alerts/Recalls
|
|