BIOMET SPINALPAK / ORTHOPAK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IN H4: MANUFACTURE DATE, G3, H6 AND H10: ADDITIONAL NARRATIVE. THERE WAS NO DATE OF BIRTH FOR THE PATIENT, (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE ELECTRODE COVER PATCHES WERE 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. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE COVER PATCHES. THE PATIENT WORE THE ELECTRODES FOR FEW DAYS. THE PATIENT CONTACTED THEIR DOCTOR AND WAS SENT WOUND TAPE TO USE. IT WAS LATER REPORTED THAT A NURSE WHO CAME TO THE PATIENT¿S HOUSE ORDERED THE TAPE. THE PATIENT STATED THAT THEY HAD A STRONG REACTION TO THE COVER PATCHES AND DEVELOPED A SIGNIFICANT RASH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE CREAM AND METHADONE CREAM FOR THE RASH WHICH TOOK ABOUT A WEEK TO CLEAR UP. NO FURTHER INFORMATION WAS PROVIDED. CSR ANAMARIA EMAILED THE REP IF HE KNEW ANYTHING ABOUT THE SKIN IRRITATION TO THE COVER PATCHES. UPDATE 16SEP2025 - PSS BRIANNE MCGILL CALLED THE PATIENT TO CONFIRM WHO PROVIDED THE WOUND TAPE TO THE PATIENT. THE PATIENT STATED THAT A NURSE WHO CAME TO HIS HOUSE HAD THE TAPE ORDERED, STATED IT IS A CLEAR TAPE WITH ADHESIVE ON THE EDGES, SIMILAR TO WHAT WOULD BE USED FOR A WOUND DRESSING. THE PATIENT WAS NOT SURE WHAT BRAND THE WOUND TAPE WAS. THE PATIENT STATED THAT THE COVER PATCHES MUST HAVE HAD LATEX IN THEM AS HE HAD A STRONG REACTION. STATED HE DEVELOPED A SIGNIFICANT RASH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE CREAM AND METHADONE CREAM TO PUT ON THE RASH. IT TOOK ABOUT A WEEK TO CLEAR UP. THE PATIENT CONFIRMED THE ISSUE WAS WITH THE COVERS AND NOT THE ELECTRODES. THE PATIENT STATED THAT HIS SKIN STILL BECOMES IRRITATED WITH THE WOUND TAPE, BUT NOT NEARLY AS BAD AS WITH THE COVER PATCHES. THE PATIENT CHANGES THE ELECTRODES EVERY 3-4 DAYS AND OCCASIONALLY TAKES A DAY OFF TO LET THE SKIN BREATH. PATIENT WAS ADVISED TO CALL BACK WITH ANY FURTHER ISSUES.

Additional Manufacturer Narrative

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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. THE DEVICE IS USED FOR TREATMENT. SECTION A: THE PATIENT'S DOB IS UNKNOWN. ATTEMPTS WILL BE MADE TO OBTAIN THE INFORMATION. SECTION B3: THE DATE OF THE EVENT IS UNKNOWN. EVENT OCCURRED IN 2025.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE COVER PATCHES. THE PATIENT WORE THE ELECTRODES FOR FEW DAYS. THE PATIENT CONTACTED THEIR DOCTOR AND WAS SENT WOUND TAPE TO USE. IT WAS LATER REPORTED THAT A NURSE WHO CAME TO THE PATIENT¿S HOUSE ORDERED THE TAPE. THE PATIENT STATED THAT THEY HAD A STRONG REACTION TO THE COVER PATCHES AND DEVELOPED A SIGNIFICANT RASH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE CREAM AND METHADONE CREAM FOR THE RASH WHICH TOOK ABOUT A WEEK TO CLEAR UP. NO FURTHER INFORMATION WAS PROVIDED.