The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The article was written by omar k.Alnachoukati, keith berend, mike kolczun, roger emerson, adolf lombardi, david mauerhan, and john barrington.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." this report is number 1 of 2 mdrs filed for the same patient (reference 3002806535-2016-00508 and 00510).Product location unknown.
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