BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Mar 30, 2026
Report 0002242816-2026-00044 · MDR key 24730370
Device
Product problems
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Pain
- Urinary Tract Infection
- Cramp(s) /Muscle Spasm(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE SPASMS. THE PATIENT HAS A 20-INCH INCISION FROM ABOUT T11 ALL THE WAY DOWN TO L5. THE PATIENT ROTATES THE PLACEMENT OF THE ELECTRODES ALONG THE INCISION, FROM TOP TO BOTTOM. THE PATIENT STATED THAT THEIR PHYSICAL THERAPIST COULD NOT WORK WITH THEM DUE TO THE FLUID BUILDUP AND BECAUSE HIS BACK MUSCLES WERE TOO TIGHT. IT WAS LATER REPORTED THAT THE PATIENT TRIED CONDUCTING A TIME TEST WITH THE DEVICE BUT CONTINUED TO EXPERIENCE BACK PAIN AFTER JUST AN HOUR OF TREATMENT. THE PATIENT ADVISED THAT THERE WAS LESS SWELLING WITH THE DECREASED TREATMENT TIME. THE PATIENT SPOKE WITH THE PRESCRIBING PHYSICIAN AND WAS ADVISED TO DISCONTINUE USE OF THE SPINALPAK DEVICE. THE PATIENT EXPERIENCED PAIN SINCE THE BEGINNING OF TREATMENT AND RATED THE PAIN LEVEL A 10 OUT OF 10. THE PATIENT STATED THAT WHEN THE ELECTRODES WERE PLACED AT THE LOWEST PART OF THE HACK, THE DEVICE SEEMED TO IRRITATE THE URINARY TRACT, SPECIFICALLY THE BLADDER AND KIDNEY AREA. DURING THE BEGINNING OF TREATMENT, THE IRRITATION WAS MINOR AS THE PATIENT ONLY KEPT THE ELECTRODES ON THE LOWER BACK FOR SHORT PERIODS OF TIME. THE IRRITATION LATER PROGRESSED TO A SEVERE URINARY TRACT INFECTION (UTI) WHICH REQUIRED ANTIBIOTICS. THE PRESCRIBING SURGEON AND THE PATIENT¿S NEPHROLOGIST FELT THE SPINALPAK DEVICE COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE UTI. THE PATIENT¿S LABS SHOWED ELEVATED PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS AND CULTURES CONFIRMED BACTERIA. THE PATIENT STATED THAT PSA LEVELS RETURNED TO NORMAL AFTER 1 WEEK OF ANTIBIOTICS. NO FURTHER INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
B3: THE DATE OF THE EVENT IS UNKNOWN. AS THE PATIENT STATED THEY WERE EXPERIENCING PAIN SINCE THE BEGINNING OF TREATMENT, THE EVENT DATE IS ESTIMATED AS OCTOBER OF 2025. H6: ADDITIONAL PATIENT CODE 4577: SWELLING/EDEMA. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION CAN 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. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR TRENDS.