Catalog Number 824MXXXX |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Spinal Column Injury (2081)
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Event Type
Injury
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Event Description
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It was reported that two pedicle screws pulled out of the bone intra-operatively, compromising the bone.The patient had very bone quality.No further information has been provided.This is report two of two for this event.
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Manufacturer Narrative
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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 3012447612-2021-00432.
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Event Description
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It was reported that two pedicle screws pulled out of the bone intra-operatively, compromising the bone.The patient had very bone quality.No further information has been provided.This is report two 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.Inspection the product was not returned so an evaluation is unable to be performed.Dhr review the lot numbers were not provided, so the dhrs were unable to be reviewed.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to poor patient bone quality or improper surgical technique.Further analysis could not be performed as lot numbers were not provided.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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Search Alerts/Recalls
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