Catalog Number 211H6025 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Loss of Range of Motion (2032)
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Event Date 07/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product code: 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 3012447612-2021-00318 through 3012447612-2021-00337.
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Event Description
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It was reported that a tether construct was removed and replaced with a fusion construct from t3-l3 due to the patient's lack of flexibility.The initial tether construct was from t5-l1.This is report 13 of 20 for this event.
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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 photos were not provided, so device evaluation could not be completed.Potential cause root cause was unable to be determined.This event could possibly be attributed to unknown patient or operational factors.Dhr review the lot number is unknown so the dhr was unable to be reviewed.Device use 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 a tether construct was removed and replaced with a fusion construct from t3-l3 due to the patient's lack of flexibility.The initial tether construct was from t5-l1.This is report 13 of 20 for this event.
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Search Alerts/Recalls
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