Catalog Number 07.02010.001 |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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 report 3012447612-2022-00244.
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Event Description
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It was reported that a closure top migrated out of a vital screw at s1 post-op.There was no reported patient harm and a revision surgery is not currently planned.This is report one of two for this event.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the products were 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 numbers were not provided, so the dhrs were 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.
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Event Description
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It was reported that a closure top migrated out of a vital screw at s1 post-op.There was no reported patient harm and a revision surgery is not currently planned.This is report one of two for this event.
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Search Alerts/Recalls
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