BIOMET SPINALPAK / ORTHOPAK

Additional Manufacturer Narrative

SECTION B3: THE ONSET DATE OF THE SKIN IRRITATION IS UNKNOWN. THE EVENT DATE IS ESTIMATED AS 2025. 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.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED SKIN IRRITATION WHEN USING THE COVER PATCHES. THE PATIENT INITIALLY HAD SKIN IRRITATION FROM THEIR DRESSING. THE COVER PATCHES WERE PLACED ON THE SAME AREA, ALSO CAUSING SKIN IRRITATION. THE PATIENT HAD WELTS AND BLISTERS. THE DOCTOR¿S OFFICE PUT THE PATIENT ON STEROIDS. THE PATIENT WAS ALSO APPLYING HYDROCORTISONE CREAM AND TAKING AN ANTIHISTAMINE. THE PATIENT HAS SENSITIVE SKIN AND IS ALLERGIC TO ADHESIVE, DERMABOND, AND PENICILLIN. THE PATIENT DISCONTINUED USE OF THE COVER PATCHES. NO FURTHER INFORMATION WAS PROVIDED.