BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM/BIOMET
Report
- Report Number
- 0002242816-2025-00104
- Event Type
- Injury
- Date Received
- August 26, 2025
- Report Date
- January 16, 2026
- Manufacturer
- EBI, LLC.
- Product Code
- LOF
- UDI-DI
- 00812301020218
- PMA / PMN Number
- P850022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTIONS IN B4: DATE OF THE REPORT. ADDITIONAL INFORMATION IN H4: MANUFACTURE DATE, G3, H6 AND H10: ADDITIONAL NARRATIVE. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE SPINALPAK CONTROLLER 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 TRENDS.
B3: DATE OF EVENT: AS THE PAIN ONSET DATE IS UNKNOWN, ESTIMATED DATE OF THE EVENT IS JULY 2025. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS WERE REVIEWED; NO DISCREPANCIES WERE FOUND. 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.
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS PAIN WHEN SHE TAKES THE STIMULATOR OFF. THE PATIENT IS UNSURE IF THE PAIN IS FROM STIMULATOR OR JUST PART OF HER HEALING. THE PATIENT IS WEARING THE STIMULATOR 2 TO 4 HOURS A DAY, HER DOCTOR RECOMMENDED TIME. THE SALES REPRESENTATIVE ADVISE THE PATIENT TO STOP USING THE UNIT FOR A FEW DAYS AND THEN TO START USING THE UNIT 30 MINUTES AND GRADUALLY INCREASE THE WEAR TIME. LATER, PATIENT INDICATED THAT SHE HAD A COMPLEX SURGERY. SHE RECENTLY HAD HER ENTIRE SPIN FUSED INCLUDING HER SHOULDER BLADES. AFTER SURGERY, THE PATIENT FELT DISCOMFORT AT A LEVEL OF 7 OR 8 OUT OF 10. ONCE BEGINNING TREATMENT WITH SPAK, SHE FEELS HER PAIN HAS INCREASED TO 8 OR 9 OUT OF 10 MOSTLY NEAR HER SHOULDER BLADES. THE PATIENT PLACES THE ELECTRODES BETWEEN T5 AND T10. MOST OF DAYS AND TREATS FOR 2-4 HOURS. HER INCREASE IN PAIN TENDS TO OCCUR AFTER SHE TAKES OFF THE UNIT. THE PATIENT ADVISED THAT SHE KNOWS THIS PAIN COULD BE FROM SURGERY BUT WANTED TO REPORT IT TO SALES REPRESENTATIVE. THE PATIENT WILL PERFORM TIME-TEST AND WILL REPORT THE PROGRESS TO SALES REP. THE PATIENT HAS NOT SPOKEN TO HER DOCTOR AS IT WAS A COMPLEX SURGERY. THE PATIENT INDICATED THAT THE TIME-TEST SEEMS TO BE WORKING. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED FOR EVALUATION.
IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE PATIENT HAS PAIN WHEN SHE TAKES THE STIMULATOR OFF. THE PATIENT IS UNSURE IF THE PAIN IS FROM STIMULATOR OR JUST PART OF HER HEALING. THE PATIENT IS WEARING THE STIMULATOR 2 TO 4 HOURS A DAY, HER DOCTOR RECOMMENDED TIME. THE SALES REPRESENTATIVE ADVISE THE PATIENT TO STOP USING THE UNIT FOR A FEW DAYS AND THEN TO START USING THE UNIT 30 MINUTES AND GRADUALLY INCREASE THE WEAR TIME. LATER, PATIENT INDICATED THAT SHE HAD A COMPLEX SURGERY. SHE RECENTLY HAD HER ENTIRE SPIN FUSED INCLUDING HER SHOULDER BLADES. AFTER SURGERY, THE PATIENT FELT DISCOMFORT AT A LEVEL OF 7 OR 8 OUT OF 10. ONCE BEGINNING TREATMENT WITH SPAK, SHE FEELS HER PAIN HAS INCREASED TO 8 OR 9 OUT OF 10 MOSTLY NEAR HER SHOULDER BLADES. THE PATIENT PLACES THE ELECTRODES BETWEEN T5 AND T10. MOST OF DAYS AND TREATS FOR 2-4 HOURS. HER INCREASE IN PAIN TENDS TO OCCUR AFTER SHE TAKES OFF THE UNIT. THE PATIENT ADVISED THAT SHE KNOWS THIS PAIN COULD BE FROM SURGERY BUT WANTED TO REPORT IT TO SALES REPRESENTATIVE. THE PATIENT WILL PERFORM TIME-TEST AND WILL REPORT THE PROGRESS TO SALES REP. THE PATIENT HAS NOT SPOKEN TO HER DOCTOR AS IT WAS A COMPLEX SURGERY. THE PATIENT INDICATED THAT THE TIME-TEST SEEMS TO BE WORKING. NO FURTHER CONSEQUENCES WERE REPORTED. SPINALPAK ASSEMBLY WAS NOT RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2779056 | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM/BIOMET | STIMULATOR, BONE GROWTH, NON-INVASIVE | LOF | EBI, LLC. | 1067716 | 00812301020218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Unknown | Other | SEE H10 NARRATIVE. |