(b)(4) initial report.
Additional information including post primary and pre revision x-rays, operative notes, patient details, patient medical history, whether the patient experienced any trauma prior to the revision and an update on the patient post revision has been requested, however, not all information could be provided and thus the scope of this investigation is limited.
It has been stated that the explanted devices are not available to return for examination.
The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.
Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
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