PROGENIX DBM PUTTY

Additional Manufacturer Narrative

(B) (4). A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL PRODUCT INFO. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE SAMPLE DEVICE IS CLEARLY LABELED "DEMONSTRATION PURPOSES ONLY NOT FOR HUMAN IMPLANTATION."

Description of Event or Problem

IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT A PT UNDERWENT AN ANTERIOR CERVICAL FUSION FROM C4-C7. THE PUTTY WAS PLACED INTO THE INTERBODY DEVICE AND IMPLANTED INTO THE PT. REPORTEDLY, AFTER PLACING THE DEVICE IN THE PT , IT WAS NOTICED THAT THE PUTTY WAS A SAMPLE, NOT LABELED FOR PT-USE. THE GRAFT WAS REMOVED AND SENT FOR CULTURE TESTING. THE CULTURE TEST CAME BACK POSITIVE FOR "EXIGUOBACTERIUM AND STREPTOMYCES BACTERIA." FOUR DAYS POST-OP, THE PT WAS DIAGNOSED WITH INTRAOPERATIVE C-SPINE CONTAMINATION. THE PT HAD A PIC-LINE INSERTED AND UNDERWENT ADDITIONAL TREATMENT AND TESTING.