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: as the day of the event is unknown, the event date is estimated as march of 2026.Use of an additional or alternative device (tens) is required to achieve an optimal outcome.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.
Event or Problem Description
The patient reported that she has been having lower back pain.The patient stated that she had the surgery 6 and a half months ago.While using the spinalpak unit consistently, the pain is a level 7.If the patient does not use the spinalpak unit, the pain goes to 4.Once the spinalpak unit is taken off, it takes about 2 days for the pain to dissipate a little bit.The patient's doctor is aware of this.The doctor does not know why she is having this pain and was told to speak to her physical therapist.The patient also uses a tens (transcutaneous electrical nerve stimulation) unit but not at the same time.The patient feels like it is muscle pain in her lower back.The doctor prescribed meloxicam and celebrex for the pain, but it did not work.The patient has slowly increased her daily activity.The patient stated that the pain intensifies the more days she uses the spinalpak unit.Then the patient stops using the spinalpak stimulator to use the tens unit, and after a few days, the pain goes down, and they start the process again of using the spinalpak stimulator.The patient was advised to stop using the spinalpak device for a few days, then start the time test and call us back with an update.No further consequences were reported.The spinalpak assembly was not returned for evaluation.

• 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 ; +1(973)299-9300
• MDR Report Key: 24886390
• Report Number: 0002242816-2026-00049
• Device Sequence Number: 21416633
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/24/2026

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: 09/21/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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: TENS UNIT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female