Catalog Number MB3XXX |
Device Problems
Expulsion (2933); Material Deformation (2976)
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Patient Problems
Pain (1994); Stenosis (2263)
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Event Type
Injury
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Event Description
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It was reported that the poly core at level c4/5 of a single-level expulsed, leading to a revision surgery where it was removed and converted to an acdf.This was detected after the patient presented with foraminal stenosis and recurrent radiculopathy.
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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.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and no photos were provided.A device evaluation could not be completed.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient, operational, or post-operative traumatic factors.Dhr review: dhr review unable to be completed as lot number is not known.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 the poly core at level c4/5 of a single-level expulsed, leading to a revision surgery where it was removed and converted to an acdf.This was detected after the patient presented with foraminal stenosis and recurrent radiculopathy.
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Search Alerts/Recalls
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