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
Per cs rep (b)(6) -received email from sales rep, (b)(6) " hi i just spoke to this patient and her daughter.I am going to give you the timeline they gave me, her sx was 1/5.She received the bone stim and started use on (b)(6) - the first day using it she had increase feeling of bowel movement every 20-30 mins wearing it.Day two on (b)(6), she ended up in the er.Did not use the stim that day.Day three on (b)(6), she was experiencing a lot of pain within 5 minutes of wearing the stim.Took stim off and pain stopped.She did say she has severe osteoarthritis.Not sure if that plays a part.I do personally think some of this/most of this might be normal healing especially with her surgery being 7 days ago.I let her know you would be in touch and hopefully we can figure something out so she can still wear it.Please keep me updated thank you.Her phone number is (b)(6) will call later as it too early to call (b)(6).I called the patient regarding the complaint.I spoke with the patient's daughter, (b)(6).The first day the patient had to go to the bathroom every 30 minutes and pain.The pain level was like an 8 or 9.The pain shooting directly into her lower spine.Two days later, the patient had severe pain.The pain level was a 1o.The pain was on the lower spine.The patient did not go to the er specifically for the bone stim.The patient went to the er because she was vomiting all morning and was in extremely pain.The patient did not use the stimulator this day.The patient has not used the unit since the second time she tried treating.The patient was told by the sales rep advise the patient not to use the unit until the sales rep got clarification.If these symptoms were from the stim.The er paperwork did not mention the stimulator.The patient is doing better from the pain right now.I advised the patient to do the time test if she has any issues.The patient will call back.No new product sent to the patient.Emailed sales rep, (b)(6) " hello, i spoke with the patient and her daughter.The patient is going to do a time test with the spinal pak.If she has any issues while treating, she will call back.Thank you, (b)(6).
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as january of 2026.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.
Event or Problem Description
Per cs rep anamaria l -received email from sales rep, charlotte beshella " hi i just spoke to this patient and her daughter.I am going to give you the timeline they gave me her sx was 1/5 i have attached her op report for reference on the levels.She received the bone stim and started use 1/9 - the first day using it she had increase feeling of bowel movement every 20-30 mins wearing it.Day two 1/10 she ended up in the er.Did not use the stim that day.Day three 1/11 she was experiencing a lot of pain within 5 minutes of wearing the stim.Took stim off and pain stopped.She did say she has severe osteoarthritis.Not sure if that plays a part.I do personally think some of this/most of this might be normal healing especially with her surgery being 7 days ago.I let her know you would be in touch and hopefully we can figure something out so she can still wear it.Please keep me updated thank you.Her phone number is (b)(6) will call later as it too early to call arizona.Al i called the patient regarding the complaint.I spoke with the patient's daughter, (b)(6).The first day the patient had to go to the bathroom every 30 minutes and pain.The pain level was like an 8 or 9.The pain shooting directly into her lower spine.Two days later, the patient had severe pain.The pain level was a 1o.The pain was on the lower spine.The patient did not go to the er ( emergency room) specifically for the bone stim.The patient went to the er ( emergency room) because she was vomiting all morning and was in extremely pain.The patient did not use the stimulator this day.The patient has not used the unit since the second time she tried treating.The patient was told by the sales rep advise the patient not to use the unit until the sales rep got clarification.If these symptoms were from the stim.The er paperwork did not mention the stimulator.The patient is doing better from the pain right now.I advised the patient to do the time test if she has any issues.The patient will call back.No new product sent to the patient.Emailed sales rep, (b)(4) " hello, i spoke with the patient and her daughter.The patient is going to do a time test with the spinal pak.If she has any issues while treating she will call back.Thank you, (b)(6).
Additional Manufacturer Narrative
Additional information in following fields - b4: date of this report, g3: date received by manufacturer, h6: evaluation codes corrected data in following fields - b2: outcomes attributed to adverse event, d4: catalog number, g1: email address and address line 2 this follow-up report is being submitted to relay additional and corrected 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: 24225347
• Report Number: 0002242816-2026-00009
• Device Sequence Number: 9366046
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 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
• Was Device Available for Evaluation?: No
• 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: 01/30/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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.
• Patient Age: 68 YR
• Patient Sex: Unknown