BIOMET EBI BONE HEALING SYSTEM

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

PATIENT HAS HAD INTERMITTENT PAIN FOR SEVERAL DAYS BUT NOT CONSECUTIVE DAYS. THERE HAVE BEEN DAYS WITH NO PAIN. WHEN SHE HAS PAIN AT NIGHT WHILE TREATING HER LEVEL OF PAIN WAS AN 8 THEN A 3 THEN ANOTHER TIME IT WAS A 4 OR 5. THE PATIENT IS AN ACHE OR DULL PAIN ON THE SIDE OF HER FOOT. THREE DAYS SHE NEEDED ICE FOR THE PAIN. SHE DID NOT CONTACT HER DOCTOR SHE CALLED RENEE PLEWA INSTEAD. THE PATIENT CLAIMS NO INCREASE IN ACTIVITY. (B)(6) DID SUGGEST WEARING A SOCK AND SHE HAD NO PAIN LAST NIGHT WHILE WEARING A SOCK. I EXPLAINED THE TIME TEST TO THE PATIENT AND SHE ADVISED SHE DOES NOT WANT TO DO IT AS SHE IS FOCUSED ON HEALING. SHE WILL UPDATE RENEE IF SHE HAS PAIN AGAIN AND LETS RENEE KNOWS IF SHE DECIDES TO DO THE TIME TEST. NO PRODUCT WAS SHIPPED. NO RETURNS.