Catalog Number 203H0012 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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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 reports 3012447612-2023-00129 through 3012447612-2023-00133.
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Event Description
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It was reported that a tether patient underwent a revision surgery to be converted to a fusion and the cord broke post-operatively.No further information has been provided.This is report five of five for this event.
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Event Description
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It was reported that a tether patient underwent a revision surgery to be converted to a fusion and the cord broke postoperatively.No further information has been provided.This is report five of five for this event.
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Manufacturer Narrative
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H6 additional method code: 4110.Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the device was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review the lot number was not provided, so the dhr was 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 unknown patient or surgical factors.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
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Search Alerts/Recalls
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