BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jul 21, 2026 · Event occurred Jun 22, 2026
Report 0002242816-2026-00091 · MDR key 25889228
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR · Male
- Limb Pain
Narrative
Additional Manufacturer Narrative
D4: THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. THEREFORE, THE DEVICE MANUFACTURE DATE (H4) COULD NOT BE DETERMINED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN. 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 FELT A BURNING PAIN DOWN HIS LEFT LEG. THE PATIENT STATED THAT THE PAIN WAS UNDER THE SKIN AND FELT LIKE IT WAS DOWN TO THE BONE. THE PATIENT STATED THAT HIS LEGS FELT WOBBLY AND THAT THE PAIN WAS VERY BAD TO THE POINT THAT HE HAD TO REMOVE THE UNIT AFTER AN HOUR. THE PATIENT CONTACTED THEIR DOCTOR WHO ADVISED THEM TO CONTACT EBI. IT WAS LATER REPORTED THAT THE PAIN BEGAN AFTER 20 TO 30 MINUTES OF TREATMENT AND BECAME UNBEARABLE AFTER ABOUT AN HOUR. THE PATIENT STATED THAT PRIOR TO SURGERY HE HAD PAIN IN HIS BACK, RIGHT HIP, AND RIGHT CALF. THERE WERE NO ISSUES WITH THE LEFT SIDE OF HIS BODY. THE PATIENT STATED THAT THE PAIN IN HIS LEFT LEG WAS SO EXCRUCIATING HE COULD NOT SLEEP. HE WAS UNABLE TO STAND UP AND GET TO THE BATHROOM. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE HE GOT A SONOGRAM WHICH CONFIRMED NO BLOOD CLOTS AS WELL AS AN X-RAY WHICH CONFIRMED NOTHING WAS BROKEN. THE PATIENT WAS GIVEN A SHOT TO MANAGE THE PAIN BUT COULD NOT RECALL WHAT THE SHOT WAS. THE STAFF IN THE EMERGENCY ROOM WAS UNABLE TO DETERMINE THE CAUSE OF THE PAIN. THE PAIN RETURNED AFTER THE SHOT WORE OFF BUT SLIGHTLY DECREASED FROM THE PAIN LEVEL IMMEDIATELY AFTER USING THE SPINALPAK DEVICE. THE PATIENT STATED THAT HE IS STILL IN PAIN, AND NOTHING SEEMS TO HELP. ICE PACKS DID NOT WORK. THE PATIENT USED A HEATING PAD WHICH HELPED A LITTLE BIT. THE PATIENT CONFIRMED THAT THE PAIN IS INTERNAL AND NOT ASSOCIATED WITH THE SKIN AT ALL. THE PATIENT HAD NOT YET SPOKEN TO THE PRESCRIBING PHYSICIAN, ONLY STAFF MEMBERS. THE PATIENT WAS HESITANT TO TRY USING THE DEVICE AGAIN AND DECIDED TO PAUSE TREATMENT UNTIL HIS FOLLOW UP APPOINTMENT WITH THE PRESCRIBING PHYSICIAN. NO FURTHER CONSEQUENCES WERE REPORTED.