ZIMMER BIOMET SPINE INC. VBT SCREW, UNKNOWN SIZE; THE TETHER - VERTEBRAL BODY TETHERING SYSTEM
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Catalog Number 211HXXXX |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Spinal Column Injury (2081)
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Event Date 10/23/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a posterior spinal fusion with lumbar vertebral tether.Upon her standing x-ray on pod 3, it was noted to list off at the l2-l3 and l3-l4 vertebra.Previously during the implant surgery, there was concern of over correcting her lumbar curve.In turn, the slack at the l2-l3 segment allowed for translation and a 33-degree curve.After discussion with the family, including the risks, benefits, complications, and alternatives, the decision was made to proceed with a revision to retighten the tether l2-l4.After retightening the tether, the curve improved to 25 degrees.This is report four of four 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 3012447612-2022-00307 through 3012447612-2022-00310.
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Manufacturer Narrative
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Device evaluation: the products were 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 patient, surgeon, or surgery 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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Event Description
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It was reported that the patient underwent a posterior spinal fusion with lumbar vertebral tether.Upon her standing x-ray on pod 3, it was noted to list off at the l2-l3 and l3-l4 vertebra.Previously during the implant surgery, there was concern of over correcting her lumbar curve.In turn, the slack at the l2-l3 segment allowed for translation and a 33-degree curve.After discussion with the family, including the risks, benefits, complications, and alternatives, the decision was made to proceed with a revision to retighten the tether l2-l4.After retightening the tether, the curve improved to 25 degrees.This is report four of four for this event.
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Search Alerts/Recalls
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