Catalog Number 211HXXXX |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Spinal Column Injury (2081)
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Event Date 08/30/2021 |
Event Type
Injury
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Event Description
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It was reported that a re-operation was performed to address not enough initial correction with tensioning.Removal and replacement of cord and set screws only.Replaced cord and set screws on levels t5 to l2 with new & re-tensioned along the whole construct.The surgeon felt that the new tensioner did not apply as much tension as expected, which contributed to the loss of correction.This is report six of twelve for this event.
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Manufacturer Narrative
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Procode: qhp.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 reports 3012447612-2022-00295 through 3012447612-2022-00306.
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Event Description
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It was reported that a re-operation was performed to address not enough initial correction with tensioning.Removal and replacement of cord and set screws only.Replaced cord and set screws on levels t5 to l2 with new & re-tensioned along the whole construct.The surgeon felt that the new tensioner did not apply as much tension as expected, which contributed to the loss of correction.This is report six of twelve for this event.
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Manufacturer Narrative
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Device evaluation: the product was 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 insufficient tension being applied to the cord as a result of unfamiliarity with the instrument.This event could also be the result of patient anatomy or other patient specific 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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Search Alerts/Recalls
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