Catalog Number 2000-2450 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2021 |
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 3012447612-2021-00478 through 3012447612-2021-00480.
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Event Description
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It was reported that during surgery, three multi-axial screw heads jammed so they lost their polyaxial motion.New screws were used to complete the case without patient impacts.This is report one of three for this event.
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Event Description
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It was reported that during surgery, three multi-axial screw heads jammed so they lost their polyaxial motion.New screws were used to complete the case without patient impacts.This is report one of three for this event.
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Manufacturer Narrative
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Device evaluation: functional inspection revealed that each screw was unable to maintain polyaxial movement without significant jamming/sticking.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown events during handling or use.Dhr review: per dhr review, the parts were likely conforming when they left zimvie control.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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Search Alerts/Recalls
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