BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Received May 23, 2025
Report 0002242816-2025-00075 · MDR key 22081047
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
66 YR · Unknown
- Headache
- Headache
Narrative
Additional Manufacturer Narrative
B3 DATE OF EVENT: ESTIMATED DATE OF EVENT IS APRIL 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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 SALES REPRESENTATIVE THAT THE PATIENT WAS HAVING HEADACHE WHILE USING SPAK UNIT. LATER CUSTOMER SERVICE REPRESENTATIVE RECEIVED VOICEMAIL FROM PATIENT INDICATED THAT SHE HAD SEVERE MIGRAINES AND THE DOCTOR TOLD HER SHE DID NOT HAVE TO CONTINUE TREATING. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT WAS HAVING HEADACHE WHILE USING SPAK UNIT. LATER CUSTOMER SERVICE REPRESENTATIVE RECEIVED VOICEMAIL FROM PATIENT INDICATED THAT SHE HAD SEVERE MIGRAINES AND THE DOCTOR TOLD HER SHE DID NOT HAVE TO CONTINUE TREATING. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION - H4: DEVICE MANUFACTURE DATE, H6: METHOD, RESULTS, CONCLUSIONS THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO HIGHRIDGE MEDICAL 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. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS.