BIOMET EBI BONE HEALING SYSTEM

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT HE IS IN PAIN. IT FEELS LIKE A NEEDLE INSIDE. IT IS A BURNING PAIN AND THE PAIN LEVEL IS WAY OVER 10. THE SKIN IS RED. THE SKIN IS SLIGHTLY WARMER THAN THE REST OF HIS BODY. ON WEDNESDAY IT LOOKED LIKE RED DOTS. TODAY IT LOOKS VERY RED ON THE AREA. THE PATIENT STARTED ABOUT 2 MONTHS AGO. THE PATIENT DID MENTION THIS TO HIS DOCTOR AND THE DOCTOR TOLD HIM THIS WAS THE HEALING PROCESS. THE PAIN IS ONLY WHEN HE IS WEARING THE UNIT. WHEN HE TAKES IT OFF THE PAIN DIMINISHES AND GOES AWAY AFTER AN HOUR OR SO. THE AREA THAT IS RED GETS IRRITATED WHEN HE IS WEARING HIS SHOES. THE CUSTOMER SERVICE REPRESENTATIVE OFFERED TO REPLACE HIS UNIT AND COIL AND THE PATIENT DECLINED SAYING HE DOES NOT WANT TO DELAY THE HEALING. HE ALSO WANTED TO REVIEW THE PLACEMENT OF THE COIL. THE CUSTOMER SERVICE REPRESENTATIVE ADVISED SHE WOULD HAVE HIS SALES REPRESENTATIVE (B)(6) CALL HIM REGARDING THIS ISSUE. THE CUSTOMER SERVICE REPRESENTATIVE CALLED (B)(6) AND EXPLAINED THE PATIENT'S ISSUE. SHE ADVISED NOT TO SEND ANY NEW PRODUCT AS SHE WILL CONTACT THE PATIENT AND ADVISE HIM TO VISIT THE DOCTOR. (B)(6) NOTED THIS MAY BE A NEW MEDICAL ISSUE SINCE THERE WAS NO PAIN FOR OVER A MONTH OF TREATING BETWEEN (B)(6)2025 AND (B)(6)2026. NO PRODUCT WAS SHIPPED. NO RETURN NOTED.

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.