BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Report
- Report Number
- 0002242816-2023-00112
- Event Type
- Injury
- Date Received
- October 25, 2023
- Report Date
- August 25, 2025
- Manufacturer
- EBI, LLC.
- Product Code
- LOF
- UDI-DI
- 00812301020218
- PMA / PMN Number
- P850022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTIONS - B4: DATE OF THIS REPORT ADDED, D3: MANUFACTURER ADDRESS AND EMAIL ADDRESS, G1: CONTACT OFFICE AND MANUFACTURER SITE, G3, G6: REPORT TYPE ADDITIONAL INFORMATION - D4: SERIAL NUMBER, D9: DEVICE AVAILABLE FOR EVALUATION AND RETURNED TO MANUFACTURER DATE, G3, H2, H3, H4: DEVICE MANUFACTURE DATE, H6: IMPACT CODE, METHOD, RESULTS, AND CONCLUSIONS, H10: ADDITIONAL NARRATIVE, H11. THE SPINALPAK ASSEMBLY WAS RECEIVED FOR EVALUATION BUT DUE TO THE NATURE OF THE COMPLAINT AND THE INFORMATION PROVIDED WITHIN THE COMPLAINT FILE, ONLY THE SPINALPAK STIMULATOR WAS EVALUATED. A VISUAL INSPECTION OF THE CUSTOMER RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS ONE SPINALPAK STIMULATOR PART NO. 1067717 WITH SERIAL NUMBER M49113 RECEIVED IN A SHIPPING BOX. THE PART RECEIVED LOOKS TO BE IN GOOD CONDITION FROM THE VISUAL/COSMETIC POINT OF VIEW. THE SPINALPAK STIMULATOR COMPLIANCE DATA WAS DOWNLOADED ON JUN 11. 2024 THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 1 DAYS 5 HOURS AND 9 MINUTES. REVIEW OF THE DHR INDICATES THAT THERE WERE NO NON-CONFORMANCES OR DEVIATIONS REPORTED. THE CLOCK LIFETIME OF THE SPINALPAK STIMULATOR WAS 287 DAYS. THE CONTROLLER AUTOMATICALLY ENTERS ¿END OF LIFETIME MODE¿ AFTER 270 DAYS AS PER DSD-00173 REVISION A AND DSD-00116-SRS (7900032) REVISION E. AT THE TIME OF THE COMPLAINT, THE UNIT WAS NOT AT ENDPOINT. THE SPINALPAK STIMULATOR WAS RESET IN ORDER TO PERFORM THE BURN IN TEST. THE SP UNIT RAN BURN-IN STAND-ALONE ¿BATTERY¿ ONLY FOR MORE THAN 24 HOURS WITH NO PROBLEM. THE MEASURED OUTPUT PERIOD WAS 16.46 USEC (SPECIFICATION - OUTPUT PERIOD FROM 15.2USEC ¿ 18.5USEC) ¿¿PASS¿. THE MEASURED OUTPUT AMPLITUDE WAS 6.00 VPP (SPECIFICATION - OUTPUT AMPLITUDE FROM 5.4VPP ¿ 6.4VPP) ¿¿PASS". ALL TESTS/INSPECTIONS WERE COMPLETED USING TEKTRONIX OSCILLOSCOPE ID OS-C001066 WITH CALIBRATION DUE ON APRIL 23, 2025; AND TF1930 S/N 02 WITH A CALIBRATION DUE DATE OF FEBRUARY 15, 2025. TEST/INSPECTIONS WERE COMPLETED BY THE QUALITY DEPARTMENT ON JUNE 18, 2024. REVIEW OF COMPLAINT HISTORY IDENTIFIED (40) TOTAL COMPLAINTS FROM (MAY 26, 2020) TO (MAY 26, 2021) FOR PN (1067716, 1067717) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: PAIN) THE SEARCH COULD NOT BE SPECIFIED FURTHER BECAUSE THE MAIN COMPLAINT WAS PAIN. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF THE "EXPERIENCED DISCOMFORT". THE UNIT WAS TESTED AND THE UNIT STOPPED BEEPING WHEN THE DUMMY LOAD WAS ENTERED. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL AND/OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "DISCOMFORT". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.
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 FOLLOWUP REPORT WILL BE SENT.
CORRECTIONS: D1: BRAND NAME, D2A: DEVICE COMMON NAME, D4: MODEL NUMBER, G4: PMA/510(K)#, H5: LABELED FOR SINGLE USE, H6: EVALUATION CODES. ADDITIONAL INFORMATION: B2, B4: DATE OF THIS REPORT, G3: DATE RECEIVED BY MANUFACTURER. UDI RELATED DATA QUALITY UPDATES ONLY - A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ADDRESS THE DISCREPANCIES BETWEEN FDA MEDWATCH FORM 3500A AND GUDID.
IT WAS REPORTED THAT THE PATIENT ON THE FIRST DAY OF TREATMENT GOT AN ELECTRICAL SHOCK FROM THE DEVICE. SHE CALLED HER DOCTOR, AND HE TOLD HER TO STOP WEARING THE DEVICE AND RETURN IT. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.
IT WAS REPORTED THAT THE PATIENT ON THE FIRST DAY OF TREATMENT GOT AN ELECTRICAL SHOCK FROM THE DEVICE. SHE CALLED HER DOCTOR, AND HE TOLD HER TO STOP WEARING THE DEVICE AND RETURN IT. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.
IT WAS REPORTED THAT THE PATIENT ON THE FIRST DAY OF TREATMENT GOT AN ELECTRICAL SHOCK FROM THE DEVICE. SHE CALLED HER DOCTOR, AND HE TOLD HER TO STOP WEARING THE DEVICE AND RETURN IT. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME. THE SPINALPAK ASSEMBLY WAS RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1433061 | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM | STIMULATOR, BONE GROWTH, NON-INVASIVE | LOF | EBI, LLC. | 1067716 | 00812301020218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Other | SEE H10 NARRATIVE| SEE H10 NARRATIVE| SEE H10 NARRATIVE |