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Model Number Y-PLATE, 1.6MM, 6 HOLE |
Device Problems
Break (1069); Difficult to Remove (1528); Material Twisted/Bent (2981)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported during a procedure the ar-18716p-10 plate was damaged during the attempted cut and the tip of the ar-18700-09 driver broke off into the screw head.Additional information provided 6/8/21: the broken tip of ar-18700-09 was unable to be removed from the screw head.The driver tip broke completely flush within the screw head and the surgeon was unable to remove it.The case was completed by removing the entire screw from the patient using a needle nose pliers, and using a less optimal plate because the most optimal plate we needed was bent during an attempted cut.Both devices were discarded.
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Search Alerts/Recalls
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