Catalog Number 7480112 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent lumbar fusion surgery due to unknown reason.Intra-op, the end of probe broke off and was easily retrieved.No fragments of the instrument remaining in the patient body.No patient complications were reported due to this event.
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Manufacturer Narrative
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Product analysis results: visual observation reveals that the tip of the probe has been sheared off and is missing from what appears to be overload.Hardness reveals that the probes are the proper hardness.This is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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