After mdr report mw5080727 was "recieved" it was determined that life spine only supplied the screws not the cage or bone graft.The mdr event description appears that there was an issue with the cage implant being too small and the graft material falling out of the cage implant.However, the mdr mw5080727 isn't clear when the screws became loose, after the first surgery or the revision surgery, so it is hard to determine why or when the screws became loose.Also without "recieiving" the screws back we are unable to determine if the screws even had issues or if it was user error.
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Life spine "recieved" an fda report mw5080727, in the report it stated that a patient had an adverse event where an interbody cage, screws and bone graft material was used.It was noted in the report that all of the products were life spine products.However, after life spine investigated the only life spine products that were used were the screws.There was never a complaint logged with life spine or a return of the screws.
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