RAPHAEL

Description of Event or Problem

PATIENT WAS VISITING OFFICE FOR FOLLOW UP AFTER A RECENT FALL. SUBJECT CONTRUCT WAS IMPLANTED/BUILT ON DATE OF (B)(6) 2022. 7-MONTH POST OPERATION X-RAY IMAGES HAVE SHOWN THAT THE PEDICLE HOUSING SET SCREW HAS SEPARATED FROM THE PEDICLE SCREW HOUSING. NO SERIOUS INJURY NOR HARM TO THE PATIENT HAS BEEN REPORTED AS OF THE DATE OF COMMUNICATION. ATTEMPTS HAVE BEEN MADE TO EXTRACT MORE INFORMATION REGARDING SURGICAL/FALL INCIDENT, BUT NO FURTHER INFORMATION FROM THE FIELD/REPRESENTATIVES HAVE BEEN PROVIDED. WITHOUT FURTHER INFORMATION, THE COMPANY DOES NOT KNOW IF FUSION HAD OCCURRED WITHIN THE PAST 6 MONTHS. WITHOUT FURTHER INFORMATION, THE CASE IS DEEMED TO BE INDETERMINATE.