Catalog Number 3306-6545 |
Device Problems
Malposition of Device (2616); Detachment of Device or Device Component (2907)
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Patient Problem
Tissue Damage (2104)
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Event Date 10/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that during a revision surgery to reposition a screw that had initially been positioned incorrectly, the screw disassembled.They created a new channel and inserted a larger screw to complete the procedure.There were no reported surgical delays or additional patient impacts.
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Manufacturer Narrative
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Additional information in d4 (udi), h4, h6 (method, results, and conclusions).The screw was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.
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Event Description
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It was reported that during a revision surgery to reposition a screw that had initially been positioned incorrectly, the screw disassembled.They created a new channel and inserted a larger screw to complete the procedure.There were no reported surgical delays or additional patient impacts.
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Search Alerts/Recalls
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