ACTIV C IMPLANT FLAT SIZE XXL 5MM

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING

Description of Event or Problem

(B)(6). THE FIRST PROSTHESIS WAS NOT PROPERLY STORED IN THE PACKAGING. BOTH PARTS CRANIAL/CAUDAL WERE NOT IN THE DESIGNATED RECEPTACLE (INNER PACKAGING). WHEN IMPLANTED INTO THE INTERVERTEBRAL SPACE, THE IMPLANT WAS TOO LOOSE ON THE INSERT INSTRUMENT AND DISLODGED/DISPLACED WHEN INSERTED INTO THE INTERVERTEBRAL SPACE AND WAS ALSO REMOVED. THE SECOND IMPLANT WAS THEN OPENED AND IT WAS IMMEDIATELY SEEN THAT IN THE INNER PACKAGING BOTH PARTS WERE NOT IN THE DESIGNATED RECEPTACLE. THEREAFTER, THE NEXT SIZE WAS TAKEN, BUT THE BONE OR THE INTERVERTEBRAL SPACE HAD TO BE FURTHER MILLED TO FIT THIS SIZE. SURGERY DELAY APPROX. 40 MIN. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: SW299K / ACTIV C IMPLANT FLAT SIZE XXL 5MM, FW866R / ACTIV C INSERTION INSTRUMENT F/H5MM.

Additional Manufacturer Narrative

(B)(4). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: IT WAS INITIALLY REPORTED THIS COMPLAINT SHOULD NOT HAVE BEEN REPORTED, THIS DEVICE WAS NOT MARKETED IN UNITED STATES. NO ADDITIONAL FOLLOW UP WILL BE FILED RELATED TO THIS ISSUE.