Catalog Number 046W0AN00002 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 3003853072-2021-00094 through 3003853072-2021-00097.
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Event Description
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It was reported the threads of three blockers and one pedicle screw were damaged intra-op.They were removed and replaced with alternate closure tops and a screw to complete the procedure without patient impacts.This is report one of four for this event.
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Manufacturer Narrative
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Device evaluation: the three returned blockers all have fractured threads and minor drive mechanism damage/deformation.Potential cause: root cause was unable to be determined.This event could possibly be attributed to off-axis forces applied during installation.Dhr review : per dhr review, the part was likely conforming when it left zimmer biomet control.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 the threads of three blockers and one pedicle screw were damaged intra-op.They were removed and replaced with alternate closure tops and a screw to complete the procedure without patient impacts.This is report one of four for this event.
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Search Alerts/Recalls
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