BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jun 4, 2026
Report 0002242816-2026-00070 · MDR key 25396003
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B2: THE DATE OF THE EVENT IS UNKNOWN AND IS ESTIMATED TO HAVE OCCURRED IN MAY OF 2026. 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.
Description of Event or Problem
THE PATIENT REPORTED THAT SHE EXPERIENCED PAIN DURING TREATMENT. THE PATIENT STATED THAT SHE USED THE UNIT FOR 1 TO 2 HOURS AND HAD TRIED TO USE THE UNIT 3 TIMES TO TREAT, AND THEN SPOKE WITH HER DOCTOR. THE DOCTOR STATED THAT SHE DOES NOT NEED TO USE IT, AS SHE IS HEALING WITHOUT IT. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.