E1: fgbu federal center for traumatology, orthopedics and endoprosthetics.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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H6: additional method code: 4112.Corrections in d4: udi number, g1, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, however photos were provided which show that the screw had disassembled.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to improper handling during surgery.Dhr review: per dhr review, the part was likely conforming when it left highridge control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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