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 11/01/2019 |
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 transforaminal lumbar interbody fusion.Intra-op, the alleged instrument broke.No fragment of the broken instrument remained inside the patient.No patient complications were reported.
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Manufacturer Narrative
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Product analysis: visual observation reveals that the tip of the probe has been broken 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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