BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jul 13, 2026
Report 0002242816-2026-00085 · MDR key 25799347
Device
Product problems
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Headache
- Pain
Narrative
Description of Event or Problem
THE PATIENT CALLED AND ADVISED THAT SHE DID NOT WANT TO RECEIVE ANY MORE SUPPLIES BECAUSE SHE IS NOT USING THE UNIT ANYMORE. SHE STATED THAT AFTER THE 2ND DAY SHE TREATED, SHE GOT SUCH A BAD HEADACHE, AND SHE STOPPED WARING THE UNIT. SHE DID NOT TAKE ANYTHING AND SHE WILL BE SEEING HER DOCTOR ON (B)(6). NO NEW PRODUCT WAS SHIPPED TO THE PATIENT. UPDATE 7/10/2026: THE PATIENT CALLED BACK AND ADVISED THAT THE PAIN LEVEL WAS A 7 OUT OF 10. SHE SPOKE WITH THE DOCTOR ABOUT THE HEADACHES BUT HER DID NOT RECOMMEND ANYTHING.
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 JUNE OF 2026. B5: THE PATIENT ADVISED THAT THE PAIN LEVEL WAS A 7 OUT OF 10, THE EVENT IS NOW CONSIDERED NON-REPORTABLE. H6: ADDITIONAL PATIENT CODE 1880: HEADACHE. 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.