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
Event or Problem Description
It was reported that the patient was experiencing pain when treating with the spinalpak device.The patient was experiencing pain since the beginning of treatment.The patient could only tolerate 30 minutes of treatment before removing the device.The pain level was rated 6 out of 10 with 10 being the highest.It was later reported that the patient spoke with the doctor who advised him to stop using the device due to the pain.No further information was provided.
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as (b)(6) 2025.Without a product return, no product evaluation is able to be conducted.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.The device is used for treatment.
Additional Manufacturer Narrative
Additional information - b4: date of this report, d8: device available for evaluation, d9: returned to manufacturer date.G3: date received by manufacturer a visual inspection of the customer returned product was performed.Included was one spinalpak stimulator part no.1067716 with serial no.(b)(6) received in a shipping mailer cushion envelope.The received product looks to be in good condition from the visual/cosmetic point of view.The failure was not confirmed for the reported condition of "pain with spinalpak".The controller was tested and operates as intended.Review of complaint history identified (36) total complaints from (dec 16, 2024) to (dec 16, 2025) 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.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.No physical and/or functional condition could be found after review of the certificate of conformance that could be considered a causal factor for the reported complaint.The reported claim could be associated with a side effect/clinical condition of the patient which is unknown.The reported condition is related to clinical factors beyond the scope of the device investigation covered in the complaint investigation as part of the manufacturing review.Therefore, no further actions are required at this time.Ebi will continue to monitor for trends.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.
Event or Problem Description
It was reported that the patient was experiencing pain when treating with the spinalpak device.The patient was experiencing pain since the beginning of treatment.The patient could only tolerate 30 minutes of treatment before removing the device.The pain level was rated 6 out of 10 with 10 being the highest.It was later reported that the patient spoke with the doctor who advised him to stop using the device due to the pain.No further information was provided.

• 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: 24208969
• Report Number: 0002242816-2026-00007
• Device Sequence Number: 17513836
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: Lay User/Patient
• Device Model Number: 1067716
• Device Catalogue Number: 1067716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: 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: 01/29/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic