BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Jul 22, 2026
Report 0002242816-2026-00092 · MDR key 25903486
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Pain
Narrative
Additional Manufacturer Narrative
SECTION B3: AS THE EVENT DATE IS UNKNOWN, IT IS ESTIMATED AS JUNE 2026. 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.
Description of Event or Problem
THE PATIENT REPORTED THAT SHE FELT PAIN WHILE WEARING THE UNIT. THE PATIENT STATED THAT SHE DROPPED THE UNIT INTO WATER. SHE HAS FELT SOME PAIN WHILE WEARING THE UNIT BUT AFTER THE DROP, THE PAIN WAS A LITTLE MORE THAN USUAL. NOT ENOUGH TO TAKE THE UNIT OFF. THE PATIENT WORE THE UNIT ALL DAY. THE PATIENT CALLED HER DOCTOR, AND HE TOLD HER SHE WOULD FEEL SOME ACHES/PAIN DURING THE HEALING PROCESS. THE PATIENT IS WEARING THE UNIT ON HER NECK. THE PATIENT IS ALSO WEARING A COLLAR. NO FURTHER CONSEQUENCES WERE REPORTED.