BIOMET SPINALPAK / ORTHOPAK

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

IT WAS REPORTED BY THE PATIENT THAT SHE IS GETTING A SKIN IRRITATION FROM THE 63B ELECTRODES. THE PATIENT CHANGES ELECTRODES AND ROTATES THEM EVERY DAY. THE PATIENT DID THE TIME TEST AND AFTER THE FIRST HOUR SHE HAD A SKIN IRRITATION. THE SKIN WAS RED AND ITCHY AND A RED MARK AROUND THE ELECTRODES. THE PATIENT DEVELOPED WELTS AND BLISTERS. THE PATIENT DID NOT CONTACT HER DOCTOR. THE SKIN WAS CLEAN WITH SOAP AND WATER. THE PATIENT DID NOT APPLY ANYTHING TO THE AFFECTED AREA. THE PATIENT STOPPED USING THE 63B ELECTRODES AROUND (B)(6) 2025. LATER, THE PATIENT STATED THAT THE DOCTOR ADVISED TO STOP USING THE UNIT DUE TO SKIN IRRITATION WITH 63B ELECTRODES. THE PATIENT ADVISED SHE HAD AN IRRITATION TO BOTH TYPES OF ELECTRODES. SHE SPOKE WITH HER DOCTOR AND WHO SAID SHE CAN DISCONTINUE IF SHE WANTS. THE PATIENT WILL CONDUCT TIME-TEST USING ELECTRODES AS ADVISED BY CUSTOMER SERVICE REPRESENTATIVE. NO FURTHER CONSEQUENCES WERE REPORTED. 63B ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

CORRECTIONS IN B4: DATE OF THE REPORT, . ESTIMATED DATE OF THE EVENT B3: MARCH 2025 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE 63B ELECTRODES WERE NOT RETURNED TO HIGHRIDGE MEDICAL FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS NOT REVIEWED. 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. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT SHE IS GETTING A SKIN IRRITATION FROM THE 63B ELECTRODES. THE PATIENT CHANGES ELECTRODES AND ROTATES THEM EVERY DAY. THE PATIENT DID THE TIME TEST AND AFTER THE FIRST HOUR SHE HAD A SKIN IRRITATION. THE SKIN WAS RED AND ITCHY AND A RED MARK AROUND THE ELECTRODES. THE PATIENT DEVELOPED WELTS AND BLISTERS. THE PATIENT DID NOT CONTACT HER DOCTOR. THE SKIN WAS CLEAN WITH SOAP AND WATER. THE PATIENT DID NOT APPLY ANYTHING TO THE AFFECTED AREA. THE PATIENT STOPPED USING THE 63B ELECTRODES AROUND (B)(6) 2025. LATER, THE PATIENT STATED THAT THE DOCTOR ADVISED TO STOP USING THE UNIT DUE TO SKIN IRRITATION WITH 63B ELECTRODES. THE PATIENT ADVISED SHE HAD AN IRRITATION TO BOTH TYPES OF ELECTRODES. SHE SPOKE WITH HER DOCTOR AND WHO SAID SHE CAN DISCONTINUE IF SHE WANTS. THE PATIENT WILL CONDUCT TIME-TEST USING 72R ELECTRODES AS ADVISED BY CUSTOMER SERVICE REPRESENTATIVE. NO FURTHER CONSEQUENCES WERE REPORTED. 63B ELECTRODES WERE NOT RETURNED FOR FURTHER EVALUATION.