Catalog Number 2000-2240 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/22/2017 |
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.
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Event Description
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It was reported that the tulip did not move about the screw shaft, as expected, during surgery.An alternative screw was used to complete the procedure.There were no reports of patient impact associated with this event.
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Manufacturer Narrative
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Additional information: the device was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Search Alerts/Recalls
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