BIOMET SPINALPAK / ORTHOPAK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, D4: LOT NUMBER AND EXPIRATION DATE, D8- YES, DEVICE AVAILABLE FOR EVALUATION, G3: DATE RECEIVED BY MANUFACTURER, H2: FOLLOW UP TYPE, H3, H4: DEVICE MANUFACTURE DATE. CORRECTED DATA: D2 ¿ COMMON DEVICE NAME, D4 ¿ CATALOG NUMBER, G4-PMA/510(K)#, H6: COMPONENT CODE, METHOD EVALUATION CODE. 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 THAT THE COVER PATCHES PULLED OUT HER SKIN, AND IT WAS VERY PAINFUL. THE SKIN WAS RED AND IRRITATED, THE PATIENT STATED THE PAIN LEVEL WAS A 10. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.

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. SECTION B3: AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS DECEMBER OF 2025.

Description of Event or Problem

THE PATIENT REPORTED THAT THE COVER PATCHES PULLED OUT HER SKIN, AND IT WAS VERY PAINFUL. THE SKIN WAS RED AND IRRITATED, THE PATIENT STATED THE PAIN LEVEL WAS A 10. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.