IN THIS CASE, A CUSTOMER INTENDED TO PLACE COMPETITOR IMPLANTS (BIOHORIZON) BY USING A SURGIGUIDE, SUBSEQUENTLY AFTER EXTENSIVELY REDUCING THE LOCAL BONE SUPPORTED BY A SIMPLANT REDUCTION GUIDE. HOWEVER, HE WAS NOT ABLE TO SEAT THE DRILL GUIDE PROPERLY, THUS HE ASSUMED THAT THE BONE WAS NOT REDUCED SUFFICIENTLY AND REMOVED MORE BONE MATERIAL FROM THE MANDIBLE. BUT STILL THE DRILL GUIDE DID NOT FIT AS DESIRED AND HE SUSPECTED THAT THE DRILLS WERE NOT ABLE TO GO DEEP ENOUGH INTO THE BONE. HE ASSUMED THAT THE GUIDING TUBES WERE LOCATED TOO HIGH IN THE GUIDE.
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Patient 1
THE INTERNAL INSPECTION REVEALED THAT THE BONE REDUCTION WAS TOO VOLUMINOUS, THUS THE IMPROPER FIT OF THE SURGICAL GUIDE OCCURRED. THEREFORE, BECAUSE TREATMENT COULD NOT BE COMPLETED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE BAD FIT OF THE DRILL GUIDE IS PROBABLY CAUSED BY THE COMPLEXITY OF THE REDUCED AREA. IT WOULD BE UNLIKELY THAT THE BONE EDGE DURING SURGERY WAS OBTAINED IN THE SAME WAY AS THE DIGITAL SIMULATION THEREOF. A REPLACEMENT ORDER AFTER A NEW SCAN WILL BE TAKEN.