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 Codes	Chest Pain (1776); Myocardial Infarction (1969); Vomiting (2144)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been returned for evaluation.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.
Event or Problem Description
It was reported that the patient experienced chest pain and vomiting while using the stimulator.The patient started using the unit around 5:00pm and reported feeling a knot in their chest by the time they went to bed.The patient removed the stimulator around 11:30pm.The patient later vomited then began to feel better around 2:30am.The patient does not know if the event was related to the spinalpak.The patient advised that it was an uncomfortable pain and rated that pain level an 8 out of 10.The patient said the feeling was very similar to heartburn but stated he does not suffer from heartburn.The patient reported no further issues after discontinuing use of the device.The patient did not contact their doctor.The patient also noted that they used the device previously in 2011 and never had any issues.It was later reported that the patient tried to use the device again and the chest tightness returned after 2 hours of treatment.They did not experience any nausea at this time.The sales representative advised the patient to discontinue use of the device until speaking with their primary care doctor.No further information was provided.
Event or Problem Description
It was reported that the patient experienced chest pain and vomiting while using the stimulator.The patient started using the unit around 5:00pm and reported feeling a knot in their chest by the time they went to bed.The patient removed the stimulator around 11:30pm.The patient later vomited then began to feel better around 2:30am.The patient does not know if the event was related to the spinalpak.The patient advised that it was an uncomfortable pain and rated that pain level an 8 out of 10.The patient said the feeling was very similar to heartburn but stated he does not suffer from heartburn.The patient reported no further issues after discontinuing use of the device.The patient did not contact their doctor.The patient also noted that they used the device previously in 2011 and never had any issues.It was later reported that the patient tried to use the device again and the chest tightness returned after 2 hours of treatment.They did not experience any nausea at this time.The sales representative advised the patient to discontinue use of the device until speaking with their primary care doctor.No further information was provided.Additional information was received that the patient's cardiologist advised that he had a heart attack when using the unit for the first time.The patient stated that his cardiologist told him that the spinalpak caused the heart attack.The patient stated that he had blockages that were being treated with medicine.No further information was provided.
Additional Manufacturer Narrative
Additional information-b2: outcomes attributed to adverse, event b4: date of this report, b5: additional narrative, g3: date received by manufacturer, h6: patient code, impact code, evaluation codes this follow-up report is being submitted to relay additional information.The device was not returned to ebi 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.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: 24172992
• Report Number: 0002242816-2026-00004
• Device Sequence Number: 10149782
• Product Code: LOF
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/12/2026

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
• Was Device Available for Evaluation?: No
• 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: 01/23/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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: N/A.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Unknown