BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

SECTION B3: DATE OF THE EVENT IS UNKNOWN. SECTION E CORRECTED ZIP CODE. ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, B5: ADDITIONAL NARRATIVE, H4: DEVICE MANUFACTURE DATE, H6: EVALUATION CODES, G3. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING (INTERNAL) WHILE TREATING, HOWEVER, SHE IS NOT SURE IF IT IS CORRELATED TO THE BONE STIMULATOR. THE PATIENT STOPPED USING IT A WEEK AGO AND STILL FEELS THE BURNING SENSATION. THE PATIENT WHO STATED THE SENSATION WAS LIGHT AT FIRST AND THEN IT GOT WORSE. WHILE TREATING THE PAIN LEVEL IS A 7 OR 8 OUT OF 10 WITH 10 BEING THE HIGHEST. IT LOWERS TO A 4 OR 5 WHEN NOT TREATING. THE PATIENT DOES HAVE A DOCTOR'S APPOINTMENT 7/9 AND DOCTOR IS GOING TO RUN TESTS TO SEE IF PATIENT HAS AN INFECTION. THE PATIENT STATED THAT SHE DID NOT HAVE ANY BURNING SENSATION PRIOR TO USING THE SPINALPAK. THE PATIENT HAS NOT USED THE UNIT FOR 3 DAYS AND THE PAIN LEVEL IS STILL AT 4. NO FURTHER CONSEQUENCES ARE REPORTED. THE SPINALPAK ASSEMBLY WAS NO RETURN 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.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING (INTERNAL) WHILE TREATING, HOWEVER, SHE IS NOT SURE IF IT IS CORRELATED TO THE BONE STIMULATOR. THE PATIENT STOPPED USING IT A WEEK AGO AND STILL FEELS THE BURNING SENSATION. THE PATIENT WHO STATED THE SENSATION WAS LIGHT AT FIRST AND THEN IT GOT WORSE. WHILE TREATING THE PAIN LEVEL IS A 7 OR 8 OUT OF 10 WITH 10 BEING THE HIGHEST. IT LOWERS TO A 4 OR 5 WHEN NOT TREATING. THE PATIENT DOES HAVE A DOCTOR'S APPOINTMENT (B)(6) AND DOCTOR IS GOING TO RUN TESTS TO SEE IF PATIENT HAS AN INFECTION. THE PATIENT STATED THAT SHE DID NOT HAVE ANY BURNING SENSATION PRIOR TO USING THE SPINALPAK. THE PATIENT HAS NOT USED THE UNIT FOR 3 DAYS AND THE PAIN LEVEL IS STILL AT 4. NO FURTHER CONSEQUENCES ARE REPORTED. THERE WAS NO PRODUCT RETURNED FOR FURTHER EVALUATION.