BIOMET EBI BONE HEALING SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, H2, H10, H11. CORRECTED DATA: D3: EMAIL ADDRESS, G1: EMAIL ADDRESS. SECTION B3: AS THE ONSET DATE OF THE PAIN IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS 2025. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

THE PATIENT REPORTED EXPERIENCING IRRITATION WITH THE COIL, THE PATIENT STATED IT IS ON THE LATERAL SIDE OF HER KNEE. PATIENT SAID THE COIL IS NOT TIGHT, IT IS A RAISED AREA. SHE WORE THE UNIT FOR 2 MONTHS STATED IT STARTED ABOUT A WEEK - 2 WEEKS AGO. PATIENT IS ACTIVE BUT NOT WITH THE UNIT. THE PATIENT USES A WALKER AND SHE TREATS AT NIGHT. THE PATIENT WAS ADVISED TO STOP WEARING THE UNIT AND CALL THE DOCTOR. PATIENT WILL CALL BACK WITH AN UPDATE. CS SPOKE WITH THE PATIENT AND SHE STATED IT IS NOT FROM THE COIL RUBBING ON HER SKIN. SALES REP STATED THAT THE DOCTOR WAS THE ONE TO CALL THEM AND REQUESTED A SWITCH TO AN OPAK. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B4- DATE OF THIS REPORT, G3- DATE RECEIVED BY MANUFACTURER, H2 ¿ FOLLOW UP TYPE CORRECTED DATA: D4- MODEL NUMBER THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR TRENDS.

Description of Event or Problem

THE PATIENT REPORTED EXPERIENCING IRRITATION WITH THE COIL, THE PATIENT STATED IT IS ON THE LATERAL SIDE OF HER KNEE. PATIENT SAID THE COIL IS NOT TIGHT, IT IS A RAISED AREA. SHE WORE THE UNIT FOR 2 MONTHS STATED IT STARTED ABOUT A WEEK - 2 WEEKS AGO. PATIENT IS ACTIVE BUT NOT WITH THE UNIT. THE PATIENT USES A WALKER AND SHE TREATS AT NIGHT. THE PATIENT WAS ADVISED TO STOP WEARING THE UNIT AND CALL THE DOCTOR. PATIENT WILL CALL BACK WITH AN UPDATE. CS SPOKE WITH THE PATIENT AND SHE STATED IT IS NOT FROM THE COIL RUBBING ON HER SKIN. SALES REP STATED THAT THE DOCTOR WAS THE ONE TO CALL THEM AND REQUESTED A SWITCH TO AN OPAK. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. 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

THE PATIENT REPORTED EXPERIENCING IRRITATION WITH THE COIL, THE PATIENT STATED IT IS ON THE LATERAL SIDE OF HER KNEE. PATIENT SAID THE COIL IS NOT TIGHT, IT IS A RAISED AREA. SHE WORE THE UNIT FOR 2 MONTHS STATED IT STARTED ABOUT A WEEK - 2 WEEKS AGO. PATIENT IS ACTIVE BUT NOT WITH THE UNIT. THE PATIENT USES A WALKER AND SHE TREATS AT NIGHT. THE PATIENT WAS ADVISED TO STOP WEARING THE UNIT AND CALL THE DOCTOR. PATIENT WILL CALL BACK WITH AN UPDATE. CS SPOKE WITH THE PATIENT AND SHE STATED IT IS NOT FROM THE COIL RUBBING ON HER SKIN. SALES REP STATED THAT THE DOCTOR WAS THE ONE TO CALL THEM AND REQUESTED A SWITCH TO AN OPAK. NO FURTHER INFORMATION WAS PROVIDED.