BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

Additional Manufacturer Narrative

B3 ESTIMATED DATE OF EVENT IS MAY 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 BY THE PATIENT IN A SURVEY THAT THE UNIT CAUSED BURNS TO THE NECK AFTER USING IT FOR 3 NIGHTS. THE PATIENT ALSO REPORTED IT ALSO MADE THE PATIENT'S NEUROPATHY REALLY BAD. THE PATIENT DISCONTINUED USING THE UNIT. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND HE USED THE UNIT FOR 3 DAYS AND THE ELECTRODES GAVE HIM RED BURN MARKS ON HIS NECK. THERE WERE NO BLISTERS AND NO ITCH. AND ON THAT THIRD NIGHT OF TREATING THE PATIENT ALSO AWOKE FROM SLEEP IN SEVERE NERVE PAIN. THE PATIENT HAS NEUROPATHY. HE FELT LIKE HIS BRAIN WAS FRIED AND HIS HANDS, ARMS, AND SHOULDERS WERE FIRED UP. HE RATED THE LEVEL OF PAIN AN 8 OUT OF 10. THE PATIENT CLAIMS IT TOOK HIM SEVERAL HOURS TO DEESCALATE HIS NERVE PAIN. HE TOOK HIS MEDICATION FOR NEUROPATHY. HE TOOK 2 PREGABALIN. HE DID NOT SEEK MEDICAL ATTENTION AT THAT TIME. HE DISCONTINUED TREATMENT. SEVERAL WEEKS LATER HE HAD A FOLLOW UP VISIT WITH HIS SURGEON AND SHE AGREED THAT SOMEHOW HIS NEUROPATHY WAS AN ISSUE AND SUPPORTED HIS DECISION TO DISCONTINUE TREATING. THE PATIENT ADVISED HE USED A CREAM ON THE SKIN ON HIS NECK AND THE SKIN CLEARED UP IN APPROXIMATELY ONE WEEK. NO PRODUCT WAS SHIPPED. NO RETURN REQUESTED. LATER, THE PATIENT INDICATED THAT THE ELECTRODES CAUSED BURN AND REDNESS. NO BUMPY SKIN, BLISTERS OR WELTS. THE PATIENT DID NOT CONTACT THE PHYSICIAN FOR RASH IRRITATION AND THE CREAM HE USED TO CLEAN UP SKIN WAS PRESCRIBED PREVIOUSLY TO HIM FOR ANOTHER REASON. NO PAIN OR DISCOMFORT ASSOCIATED WITH ELECTRODES. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY HAS NOT BEEN RECEIVED.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT IN A SURVEY THAT THE UNIT CAUSED BURNS TO THE NECK AFTER USING IT FOR 3 NIGHTS. THE PATIENT ALSO REPORTED IT ALSO MADE THE PATIENT'S NEUROPATHY REALLY BAD. THE PATIENT DISCONTINUED USING THE UNIT. THE CUSTOMER SERVICE REPRESENTATIVE CALLED THE PATIENT AND FOUND HE USED THE UNIT FOR 3 DAYS AND THE ELECTRODES GAVE HIM RED BURN MARKS ON HIS NECK. THERE WERE NO BLISTERS AND NO ITCH. AND ON THAT THIRD NIGHT OF TREATING THE PATIENT ALSO AWOKE FROM SLEEP IN SEVERE NERVE PAIN. THE PATIENT HAS NEUROPATHY. HE FELT LIKE HIS BRAIN WAS FRIED AND HIS HANDS, ARMS, AND SHOULDERS WERE FIRED UP. HE RATED THE LEVEL OF PAIN AN 8 OUT OF 10. THE PATIENT CLAIMS IT TOOK HIM SEVERAL HOURS TO DEESCALATE HIS NERVE PAIN. HE TOOK HIS MEDICATION FOR NEUROPATHY. HE TOOK 2 PREGABALIN. HE DID NOT SEEK MEDICAL ATTENTION AT THAT TIME. HE DISCONTINUED TREATMENT. SEVERAL WEEKS LATER HE HAD A FOLLOW UP VISIT WITH HIS SURGEON AND SHE AGREED THAT SOMEHOW HIS NEUROPATHY WAS AN ISSUE AND SUPPORTED HIS DECISION TO DISCONTINUE TREATING. THE PATIENT ADVISED HE USED A CREAM ON THE SKIN ON HIS NECK AND THE SKIN CLEARED UP IN APPROXIMATELY ONE WEEK. NO PRODUCT WAS SHIPPED. NO RETURN REQUESTED. LATER, THE PATIENT INDICATED THAT THE ELECTRODES CAUSED BURN AND REDNESS. NO BUMPY SKIN, BLISTERS OR WELTS. THE PATIENT DID NOT CONTACT THE PHYSICIAN FOR RASH IRRITATION AND THE CREAM HE USED TO CLEAN UP SKIN WAS PRESCRIBED PREVIOUSLY TO HIM FOR ANOTHER REASON. NO PAIN OR DISCOMFORT ASSOCIATED WITH ELECTRODES. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED FOR FURTHER EVALUATION.

Additional Manufacturer Narrative

CORRECTIONS IN B4: DATE OF THE REPORT, ADDITIONAL INFORMATION IN B5, G3, H6 AND H10: ADDITIONAL NARRATIVE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL 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.