Catalog Number 25740018580 |
Device Problems
No Apparent Adverse Event (3189); Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/29/2020 |
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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Intra-op, the set screw had come off from the ballast screw placed on the caudal side.Hence the ballast screw is explanted.
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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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Event Description
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As per the update received, there is no issue with the reported screw.
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Search Alerts/Recalls
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