MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM; STIMULATOR, BONE GROWTH, NON-INVASIVE,

Model Number	1067716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: the date of the event is unknown and is estimated to have occurred in january of 2026.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.
Event or Problem Description
It was reported by the patient that the device is causing her pain.The patient states that it started about two weeks after using the unit.The patient reported that she had discontinued wearing the unit.The pain level is a 9.The patient is taking percocet for the pain.The patient called her doctor and is awaiting a return call.The patient will call back with an update.No further consequences were reported.The spinalpak was not returned.
Event or Problem Description
It was reported by the patient that the device is causing her pain.The patient states that it started about two weeks after using the unit.The patient reported that she had discontinued wearing the unit.The pain level is a 9.The patient is taking percocet for the pain.The patient called her doctor and is awaiting a return call.The patient will call back with an update.No further consequences were reported.It was later reported that the patient spoke with their doctor and was advised to discontinue treatment with the device.No further consequences were reported.
Additional Manufacturer Narrative
Additional information in following fields- b2: outcomes attributed to adverse event, b4: date of this report, b5: additional narrative, d8-9: device available for evaluation and returned to manufacturer date, g3: date received by manufacturer, h3: device evaluated by manufacturer, h6: impact code and evaluation codes corrected data in following fields ¿ d4: unique identifier (udi) number this follow-up report is being submitted to relay additional and corrected information.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.The part received looks to be in good condition from the visual/cosmetic point of view.The compliance data for the spinalpak stimulator was downloaded on may 28, 2026.The compliance data indicates the unit treated for 8 days 6 hours and 36 minutes.Review of the dhr indicates that unit was manufactured on october 21, 2025.There were no non-conformances or deviations reported on the dhr.The spinalpak unit ran for on battery power only for more than 24 hours with no problem.The measured output period was 16.4 usec (specification - output period from 15.2usec ¿ 18.5usec) ¿¿pass¿.The measured output amplitude was 5.6 vpp (specification - output amplitude from 5.4vpp ¿ 6.4vpp) ¿¿pass".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 (34) total complaints from (january 21, 2025) to (january 21, 2026) for pn (1067716, 1067717) and events related to (pain).The search could not be specified further because the main complaint was pain.The device is used for treatment.Ebi will continue to monitor trends.

• Brand Name: BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE,
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 24293973
• Report Number: 0002242816-2026-00012
• Device Sequence Number: 9426631
• Product Code: LOF
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 1067716
• Device Catalogue Number: 1067716
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown