Model Number N/A |
Device Problems
Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/06/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This user facility is outside of the united states.Current information is insufficient to permit a conclusion to the cause of the event.Product location unknown.
|
|
Event Description
|
It was reported the seal of a cement package had been breached.There was no patient injury and another unit was available to complete the procedure without delay.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).
|
|
Search Alerts/Recalls
|