Catalog Number 9561524 |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2018 |
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 discectomy due to spinal stenosis.During the procedure, the flexible arm could not be fixed.The product came in contact with the patient.No patient complications were reported as a result of the event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product analysis: it appears the ¿cups¿ inside the joints of the flex arm are worn and will no longer lock up when tightened.This is consistent with anticipated wear.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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