ZIMMER BIOMET SPINE INC. SCREW VBT ASSY, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
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Catalog Number 211H60XX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/04/2023 |
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 3012447612-2023-00137 through 3012447612-2023-00149.
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Event Description
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It was reported that the patient's left ureter was damaged during a tether procedure.It is not clear when this occurred, as it was not immediately noticed.Post-operatively, the subject had increased output from their chest tube, and urology was consulted.They performed creatinine levels on the output from the chest tube, and confirmed the ureter damage via ct scan.The patient was taken to the or to repair the damage.A nephrostomy bag was temporarily placed to alleviate pressure in the left kidney.There is a plan for stent placement in the left ureter around the repair site.The reporter also reported this event to fda via voluntary medwatch report mw5116753.This is report eleven of thirteen for this event.
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Manufacturer Narrative
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H6: additional method code: 4109.Device evaluation: the products were not returned, however patient documentation was provided.Device evaluation could not be completed.The tether implants are unrefuted for involvement in a revision leading to patient harm.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient factors, operational factors, or surgical factors.Dhr review: dhr review unable to be performed as lot information is not known.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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Event Description
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It was reported that the patient's left ureter was damaged during a tether procedure.It is not clear when this occurred, as it was not immediately noticed.Post-operatively, the subject had increased output from their chest tube, and urology was consulted.They performed creatinine levels on the output from the chest tube, and confirmed the ureter damage via ct scan.The patient was taken to the or to repair the damage.A nephrostomy bag was temporarily placed to alleviate pressure in the left kidney.There is a plan for stent placement in the left ureter around the repair site.The reporter also reported this event to fda via voluntary medwatch report mw5116753.This is report eleven of thirteen for this event.
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Search Alerts/Recalls
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