BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received Aug 29, 2025
Report 0002242816-2025-00105 · MDR key 22922310
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
83 YR · Female
- Pain
- Cramp(s) /Muscle Spasm(s)
- Pain
- Cramp(s) /Muscle Spasm(s)
Narrative
Additional Manufacturer Narrative
WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED; HOWEVER, NO DISCREPANCIES WERE IDENTIFIED. 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 BY THE PATIENT THAT WHILE USING SPINALPAK UNIT, THE PATIENT EXPERIENCES MUSCLE SPAMS ON THE RIGHT SIDE OF FUSION. THE PATIENT STATED THAT THEY HAVE PAIN MOST OF THE DAYS AND IT WAS AROUND 10 WHEN THE PATIENT MOVES. THE PATIENT IS WEARING THE UNIT DURING THE DAY. THE PATIENT DOES NOT USE THE UNIT WHILE SLEEPING, HOWEVER STILL EXPERIENCES PAIN. THE CS ADVISED THE PATIENT NOT TO USE UNIT FOR FEW DAYS. THE HAS SPOKEN TO THE DOCTOR REGARDING PAIN AND WAS ADVISED THAT IT IS PROBABLY FROM SPAK. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT WHILE USING SPINALPAK UNIT, THE PATIENT EXPERIENCES MUSCLE SPAMS ON THE RIGHT SIDE OF FUSION. THE PATIENT STATED THAT THEY HAVE PAIN MOST OF THE DAYS AND IT WAS AROUND 10 WHEN THE PATIENT MOVES. THE PATIENT IS WEARING THE UNIT DURING THE DAY. THE PATIENT DOES NOT USE THE UNIT WHILE SLEEPING, HOWEVER STILL EXPERIENCES PAIN. THE CS ADVISED THE PATIENT NOT TO USE UNIT FOR FEW DAYS. THE HAS SPOKEN TO THE DOCTOR REGARDING PAIN AND WAS ADVISED THAT IT IS PROBABLY FROM SPAK. NO FURTHER CONSEQUENCES WERE REPORTED. THE SPINALPAK ASSEMBLY WAS NOT RETURNED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER, H2, H6: EVALUATION CODES, H10, H11. CORRECTED DATA: D3: EMAIL ADDRESS, D4: CATALOG NUMBER, G1: EMAIL ADDRESS. SECTION B3: THE DATE OF THE EVENT IS UNKNOWN. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE DEVICE WAS NOT RETURNED TO EBI FOR EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. THE DEVICE IS USED FOR TREATMENT. EBI WILL CONTINUE TO MONITOR FOR TRENDS.