BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
Report
- Report Number
- 0002242816-2024-00142
- Event Type
- Injury
- Date Received
- November 7, 2024
- Date of Event
- September 30, 2024
- Report Date
- November 6, 2024
- Manufacturer
- EBI, LLC.
- Product Code
- LOF
- UDI-DI
- 00812301020218
- PMA / PMN Number
- P850022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: G3: DATE RECEIVED BY MANUFACTURER, H6: METHOD, RESULTS, CONCLUSIONS. SECTION B3: THE EVENT DATE HAS BEEN ESTIMATED AS OCTOBER OF 2024 AS THE DAY OF THE EVENT IS UNKNOWN. 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 (B)(6) 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 (B)(6) 2025. THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 2 DAYS 7 HOURS AND 33 MINUTES. REVIEW OF THE DHR INDICATES THAT UNIT WAS MANUFACTURED ON JULY 29, 2024. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS REPORTED ON THE DHR. THE SP UNIT RAN BURN-IN STAND-ALONE ¿BATTERY¿ ONLY FOR MORE THAN 24 HOURS WITH NO PROBLEM. THE MEASURED OUTPUT PERIOD WAS 15.3 USEC (SPECIFICATION - OUTPUT PERIOD FROM 15.2USEC ¿ 18.5USEC) ¿¿PASS¿. THE MEASURED OUTPUT AMPLITUDE WAS 6.2 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 (B)(6) 2025; AND TF1930 S/N (B)(6) WITH A CALIBRATION DUE DATE OF (B)(6)2025. TEST/INSPECTIONS WERE COMPLETED BY THE QUALITY DEPARTMENT ON (B)(6) 2025. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF THE "EXPERIENCED PAIN". 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 "PAIN". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. REVIEW OF COMPLAINT HISTORY IDENTIFIED (B)(4) TOTAL COMPLAINTS FROM ((B)(6) 2020) TO ((B)(6) 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. HIGHRIDGE MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.
SECTION B3: THE EVENT DATE HAS BEEN ESTIMATED. AS THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS, AN EVALUATION WILL BE CONDUCTED AND THE DEVICE HISTORY RECORDS WILL 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.
IT WAS REPORTED THAT THE DEVICE WAS CAUSING THE PATIENT PAIN. THE PATIENT WORE THE DEVICE CONSTANTLY. THE PATIENT TOLD THEIR DOCTOR ABOUT THE PAIN AND STATED THAT THE DOCTOR DID NOT SAY ANYTHING. THE PATIENT STATED THAT SHE HAD TO GO BACK TO THE HOSPITAL DUE TO THE PAIN. THE PATIENT WAS ADVISED BY A CUSTOMER SERVICE REPRESENTATIVE TO CONTACT HER DOCTOR, BUT SHE SAID NO AND INSISTED SHE DID NOT WANT THE DEVICE ANYMORE. IT WAS LATER REPORTED THAT THE PATIENT WAS FEELING PAIN ON HER LEFT SIDE. THE PATIENT WENT TO THE HOSPITAL FOR 7 DAYS DUE TO SEVERE SWELLING AND PAIN. THE PATIENT RATED HER PAIN LEVEL AS A 10 ON A SCALE OF 1-10, WITH 10 BEING THE HIGHEST. THE PATIENT WAS PRESCRIBED OXYCODONE AT THE HOSPITAL. IT WAS NOTED THAT THE EFFECT OF THE MEDICATION LASTS ONLY 5 OR 6 HOURS. THE PATIENT IS STILL EXPERIENCING SWELLING AND PAIN AFTER STOPPING TREATMENT WITH THE DEVICE. THE PATIENT DID NOT DISCUSS ANY ALTERNATIVE TREATMENT WITH HER DOCTOR.
IT WAS REPORTED THAT THE DEVICE WAS CAUSING THE PATIENT PAIN. THE PATIENT WORE THE DEVICE CONSTANTLY. THE PATIENT TOLD THEIR DOCTOR ABOUT THE PAIN AND STATED THAT THE DOCTOR DID NOT SAY ANYTHING. THE PATIENT STATED THAT SHE HAD TO GO BACK TO THE HOSPITAL DUE TO THE PAIN. THE PATIENT WAS ADVISED BY A CUSTOMER SERVICE REPRESENTATIVE TO CONTACT HER DOCTOR, BUT SHE SAID NO AND INSISTED SHE DID NOT WANT THE DEVICE ANYMORE. IT WAS LATER REPORTED THAT THE PATIENT WAS FEELING PAIN ON HER LEFT SIDE. THE PATIENT WENT TO THE HOSPITAL FOR 7 DAYS DUE TO SEVERE SWELLING AND PAIN. THE PATIENT RATED HER PAIN LEVEL AS A 10 ON A SCALE OF 1-10, WITH 10 BEING THE HIGHEST. THE PATIENT WAS PRESCRIBED OXYCODONE AT THE HOSPITAL. IT WAS NOTED THAT THE EFFECT OF THE MEDICATION LASTS ONLY 5 OR 6 HOURS. THE PATIENT IS STILL EXPERIENCING SWELLING AND PAIN AFTER STOPPING TREATMENT WITH THE DEVICE. THE PATIENT DID NOT DISCUSS ANY ALTERNATIVE TREATMENT WITH HER DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46862 | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM | SPINALPAK ASSEMBLY | LOF | EBI, LLC. | 1067716 | 00812301020218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Hospitalization| R | SEE H10 NARRATIVE.| SEE H10 NARRATIVE. |