{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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ACCORDING TO THE LOCAL TEAM, THE SURVEILLANCE WAS FINE AND THE MERGE WAS ACCEPTABLE. THE PATIENT IS DOING WELL BUT HAD A SMALL DURAL SCRATCH WHICH WAS REPAIRED INTRA-OPERATIVELY WITH NO SERIOUS LONG-TERM EFFECT TO THE PATIENT." }, { "mdr_text_key": "337465168", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MDR IS BEING SUBMITTED FOR AN EVENT THAT OCCURRED EARLIER. ENGINEERING INVESTIGATION REVEALED THAT THE USER ACCEPTED SHIFTED REGISTRATION BETWEEN PATIENT PREOPERATIVE CT SCAN AND INTRA-OPERATIVE FLUOROSCOPIC IMAGES. THE REGISTRATION SHIFT WAS DUE TO THE POSITION OF THE FLUOROSCOPE TRACKER AT THE TIME OF IMAGE CAPTURE BEING INCONSISTENT WITH ITS POSITION WHEN THE X-RAY SHOT WAS ACTUALLY TAKEN. THE SHIFT WAS VISIBLE TO THE USER VIA THE MARKED CENTER (CENTROID) OF EACH VERTEBRA ON EACH IMAGE - IMAGES SHOULD NOT BE USED FOR WHICH THE CENTROID MARKS A DIFFERENT POINT ON THE ANTERIOR-POSTERIOR (AP) AND LATERAL SHOTS. THE USER IS REQUIRED TO REVIEW AND VERIFY THE REGISTRATION BEFORE PROCEEDING. FURTHER, THE USER IS ENCOURAGED TO PERFORM A LANDMARK CHECK TO CONFIRM NAVIGATION ACCURACY. THERE WAS NO MALFUNCTION OF SOFTWARE. THE USER ACCEPTED FLUOROSCOPIC IMAGES WHICH WERE SUBOPTIMAL FOR REGISTRATION. THE IMAGES WERE CAPTURED SUCH THAT THE POSITION OF THE FLUOROSCOPE TRACKER WAS INCONSISTENT WITH THE X-RAY SHOT ASSOCIATED. DUE TO EXISTING MITIGATION, THERE IS NO UNACCEPTABLE RISK TO HEALTH." }, { "mdr_text_key": "349146588", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SYSTEM PLACED SCREWS AT LL AND L4 ACCURATELY, BUT L2 AND L3 WERE WAY OFF. ACCORDING TO THE LOCAL TEAM, THE SURVEILLANCE WAS FINE AND THE MERGE WAS ACCEPTABLE. THE PATIENT IS DOING WELL BUT HAD A SMALL DURAL SCRATCH WHICH WAS REPAIRED INTRA-OPERATIVELY WITH NO SERIOUS LONG-TERM EFFECT TO THE PATIENT." }, { "mdr_text_key": "349146589", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MDR IS BEING SUBMITTED FOR AN EVENT THAT OCCURRED EARLIER. ENGINEERING INVESTIGATION REVEALED THAT THE USER ACCEPTED SHIFTED REGISTRATION BETWEEN PATIENT PREOPERATIVE CT SCAN AND INTRA-OPERATIVE FLUOROSCOPIC IMAGES. THE REGISTRATION SHIFT WAS DUE TO THE POSITION OF THE FLUOROSCOPE TRACKER AT THE TIME OF IMAGE CAPTURE BEING INCONSISTENT WITH ITS POSITION WHEN THE X-RAY SHOT WAS ACTUALLY TAKEN. THE SHIFT WAS VISIBLE TO THE USER VIA THE MARKED CENTER (CENTROID) OF EACH VERTEBRA ON EACH IMAGE - IMAGES SHOULD NOT BE USED FOR WHICH THE CENTROID MARKS A DIFFERENT POINT ON THE ANTERIOR-POSTERIOR (AP) AND LATERAL SHOTS. THE USER IS REQUIRED TO REVIEW AND VERIFY THE REGISTRATION BEFORE PROCEEDING. FURTHER, THE USER IS ENCOURAGED TO PERFORM A LANDMARK CHECK TO CONFIRM NAVIGATION ACCURACY. THERE WAS NO MALFUNCTION OF SOFTWARE. THE USER ACCEPTED FLUOROSCOPIC IMAGES WHICH WERE SUBOPTIMAL FOR REGISTRATION. THE IMAGES WERE CAPTURED SUCH THAT THE POSITION OF THE FLUOROSCOPE TRACKER WAS INCONSISTENT WITH THE X-RAY SHOT ASSOCIATED. DUE TO EXISTING MITIGATION, THERE IS NO UNACCEPTABLE RISK TO HEALTH." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "19403", "manufacturer_contact_exchange": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/25/2024" } ] }