Catalog Number 046W0AN26540 |
Device Problem
Unintended Movement (3026)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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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 3003853072-2020-00008 to 3003853072-2020-00020.
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Event Description
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It was reported that an instinct java spondylolisthesis correction construct was found to have failed 1.5 months postoperatively after the patient presented for low back pain.There were no additional patient impacts reported and no revision is scheduled at this time.This is report fourteen of fourteen for this event.
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Manufacturer Narrative
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The product was not returned and no photos were provided, so an evaluation is unable to be performed.The lot number was not provided and a device history review cannot be conducted.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.Provided x-rays demonstrate the recurrence of the spondylolisthesis.The complaint is confirmed.A definitive root cause cannot be determined.
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Event Description
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It was reported that an instinct java spondylolisthesis correction construct was found to have failed 1.5 months postoperatively after the patient presented for low back pain.There were no additional patient impacts reported and no revision is scheduled at this time.This is report fourteen of fourteen for this event.
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Search Alerts/Recalls
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