Catalog Number UNK_ICO |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Extravasation (1842)
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Event Date 02/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Product implanted in patient.
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Event Description
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It was reported that during a surgical procedure, the bone cement migrated outside the vertebral body causing an extravasation event.It was also reported that the event caused a change to the surgical procedure to remove the migrated cement.It was further reported that the event contributed to a 120 minute delay.It was also reported that there was no adverse consequences to the patient as a result of this event.It was further reported that the procedure was completed successfully.
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Manufacturer Narrative
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H6: the quality investigation is complete.H3 other text : product implanted in patient.
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Event Description
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It was reported that during a surgical procedure, the bone cement migrated outside the vertebral body causing an extravasation event.It was also reported that the event caused a change to the surgical procedure to remove the migrated cement.It was further reported that the event contributed to a 120 minute delay.It was also reported that there was no adverse consequences to the patient as a result of this event.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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