SPINALOGIC BONE GROWTH STIMULATOR

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: IT WAS REPORTED THAT THEY WERE GETTING THE 065/271 MESSAGE WITH A HAPPY FACE ON THEIR CONTROLLER AND THE ISSUE BEGAN A COUPLE OF YEARS AGO. PATIENT STATED WHEN THEY PRESSED THE BUTTON, THEY GOT A HAPPY FACE AND NOTHING ELSE HAPPENED. PATIENT CONFIRMED THEY HAD A DJO SPINALOGIC BONE GROWTH STIMULATOR. PATIENT ALSO NOTED AFTER THEY USED THEIR BONE GROWTH STIMULATOR, THEY HAD 3 MORE LAMINECTOMIES AND HAD A HEMORRHAGIC STROKE ON THE TABLE. PATIENT MENTIONED THEIR DOCTOR WANTED TO CUT THEM AGAIN AND THEIR BACK WAS KILLING THEM SO THEY WERE GOING TO HAVE SURGERY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).