BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

AS THE DAY OF THE EVENT IS UNKNOWN, THE EVENT DATE IS ESTIMATED AS APRIL OF 2026. 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.

Description of Event or Problem

THE SALES REP REPORTED THAT THE PATIENT EXPERIENCED PAIN DURING TREATMENT. THE PATIENT WORE THE DEVICE FROM HIS APPOINTMENT FITTING AND TOOK IT OFF AT 11PM; THERE WAS NO PAIN. THE PATIENT STATED THAT HE WOKE UP AT 1:30 AM IN SEVERE PAIN AND ALMOST WANTED TO GO TO THE EMERGENCY ROOM. THE PATIENT SAID THE PAIN WAS WHERE THE FUSION WAS AND POSSIBLY RADIATING DOWN HIS LEGS. THIS MORNING, THE PAIN HAS SUBSIDED AND IS NEAR NORMAL FOR SURGICAL HEALING PAIN. THE PATIENT STATED HE DID NOT TURN ON HIS MEDTRONIC PAIN STIMULATOR LAST NIGHT OR WHILE WEARING THE SPINAL PAK DEVICE. NO REPLACEMENT PRODUCT WAS SHIPPED. IT WAS LATER REPORTED THAT CUSTOMER SERVICE RECEIVED A CALL BACK FROM THE PATIENT, WHO STATED HE HAD PUT THE STIMULATOR ON YESTERDAY. HE STATED THE STIMULATOR CAUSED SIGNIFICANT, CONSTANT PAIN AND THAT THE PAIN KEPT HIM UP ALL NIGHT. THE PATIENT RATED THE PAIN LEVEL AT A 9. THE PATIENT DID NOT CALL THE DOCTOR. THE PATIENT ADVISED THAT THE SALES REP WOULD CONTACT HIS DOCTOR. THE PATIENT SAID THAT HE TOOK TRAMADOL AND TYLENOL FOR THE PAIN. THE PATIENT CALLED BACK AGAIN. CUSTOMER SERVICE EXPLAINED THAT ALL INFORMATION REGARDING THE DISCOMFORT HAD BEEN COLLECTED. THE PATIENT EXPLAINED HE WAS WAITING FOR SOMEONE TO CALL HIM BACK AFTER SPEAKING WITH HIS DOCTOR. NO FURTHER CONSEQUENCES WERE REPORTED.