AS STATED IN THE EVENT DESCRIPTION, AD-TECH WAS MADE AWARE OF AN ISSUE VIA EMAIL ON (B)(6) 2017. THE EMAIL STATED THAT AN ANCHOR BOLT WAS FOUND TO BE BROKEN AND THE END REMAINS IN SITU IN THE PATIENT'S SKULL. THE BOLT WAS FRACTURED UPON REMOVAL. THE CAP WAS ESSENTIALLY HELD PROXIMATE TO THE INTRACRANIAL BOLT REMNANT BY THE INDWELLING ELECTRODE. UPON REMOVAL OF THE ELECTRODE, THE CAP AND PROXIMAL END OF THE ANCHOR BOLT WERE FREED. THE TEAM OPTED TO LEAVE THE BOLT FRAGMENT IN SITU AS THIS BOLT WAS IN THE RIGHT OCCIPITAL REGION, IN THE EXPECTED SURGICAL FIELD OF ANY RESECTION. THE BOLT FRAGMENT MAY BE RETRIEVED SHOULD THE PATIENT COME TO CRANIOTOMY. ACCORDING TO THE DOCTOR, THE PATIENT WAS RESTRICTED TO BED FOR MOST OF 7 DAYS, HAD EXCLUSIVELY NON-CONVULSIVE PARTIAL SEIZURES, AND NO APPARENT TRAUMA OR VOLITIONAL MANIPULATION UPON REVIEW OF VIDEO. THE PRODUCT WAS NOT SENT BACK TO AD-TECH FOR EVALUATION. INSTEAD, A PICTURE WAS SENT SHOWING THE BROKEN BOLT. BASED ON THE PICTURE, THE ALLEGED DEFICIENCY IN THE COMPLAINT WAS CONFIRMED. THIS INVESTIGATION IS STILL ON-GOING.
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Patient 1
AD-TECH RECEIVED AN EMAIL FROM A REPRESENTATIVE AT (B)(6) ON (B)(6) 2017 STATING THAT AN ANCHOR BOLT WAS FOUND TO BE BROKEN AND THE END REMAINS IN SITU IN THE PATIENT'S SKULL. THE BOLT HAD FRACTURED UPON REMOVAL. THE CAP WAS HELD PROXIMATE TO THE INTRACRANIAL BOLT REMNANT BY THE INDWELLING ELECTRODE. UPON REMOVAL OF THE ELECTRODE, THE CAP AND PROXIMAL END OF THE ANCHOR BOLT WERE FREED. THE TEAM OPTED TO LEAVE THE BOLT FRAGMENT IN SITU AS THIS BOLT WAS IN THE RIGHT OCCIPITAL REGION, IN THE EXPECTED SURGICAL FIELD OF ANY RESECTION. THE PATIENT WAS RESTRICTED TO BED FOR MOST OF 7 DAYS AND HAD EXCLUSIVELY NON-CONVULSIVE PARTIAL SEIZURES. ACCORDING TO THE CUSTOMER, THERE WAS NO APPARENT TRAUMA OR VOLITIONAL MANIPULATION TO THE PATIENT UPON REVIEW OF THE VIDEO.