Catalog Number 7208000000 |
Device Problem
Disassembly (1168)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 12/22/2016 |
Event Type
malfunction
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Event Description
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It was reported that during a surgical procedure at the user facility that the device ball bearing fell off the device and into the patient.The ball bearing was retrieved and the patient was given an x-ray to ensure that no additional material was in the patient.The x-ray showed that no additional material was within the patient.The procedure was completed successfully without a clinically significant delay.
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Manufacturer Narrative
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Supplemental submitted to document device evaluation results.
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Event Description
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It was reported that during a surgical procedure at the user facility that the device ball bearing fell off the device and into the patient.The ball bearing was retrieved and the patient was given an x-ray to ensure that no additional material was in the patient.The x-ray showed that no additional material was within the patient.The procedure was completed successfully without a clinically significant delay.
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Search Alerts/Recalls
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