MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM; ELECTRODE COVER PATCHES

Model Number	106130-17
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient who stated that last week she had a skin reaction.The patient stated that the irritation started on (b)(6) 2023.The patient had a doctor¿s appointment.The patient stated she was told by the doctor to remove them for a few days and to apply aloe vera (fresh from plant) the skin was burning and itchy, red with little welts.The patient was changing and moving the electrodes and cover patches every day.The area was clean with soap and water and alcohol wipes.The patient was using the aloe vera to refresh the area.The patient is allergic to iodine, sofran and adhesive.No seasonal allergies, patient does not have sensitive skin.The patient's skin is not irritated now, she is no longer using the cover patches and changing the electrodes daily.No further consequences have been reported.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 who stated that last week she had a skin reaction.The patient stated that the irritation started on (b)(6) s2023.The patient had a doctor¿s appointment.The patient stated she was told by the doctor to remove them for a few days and to apply aloe vera (fresh from plant) the skin was burning and itchy, red with little welts.The patient was changing and moving the electrodes and cover patches every day.The area was clean with soap and water and alcohol wipes.The patient was using the aloe vera to refresh the area.The patient is allergic to iodine, sofran and adhesive.No seasonal allergies, patient does not have sensitive skin.The patient's skin is not irritated now, she is no longer using the cover patches and changing the electrodes daily.No further consequences have been reported.The product was not returned for evaluation.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
Additional Manufacturer Narrative
Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies betweenfda medwatch form 3500a and gudid.Corrections: d1: brand name, d2a: device common name, d4: model number, d4:expiration date, h4: device manufacture date, h5: labeled for single use, h6: evaluation codes.Additional information: b4: dateof this report, g3: date received by manufacturer.
Event or Problem Description
The patient who stated that last week she had a skin reaction.The patient stated that the irritation started on (b)(6) 2023.The patient had a doctor¿s appointment.The patient stated she was told by the doctor to remove them for a few days and to apply aloe vera (fresh from plant) the skin was burning and itchy, red with little welts.The patient was changing and moving the electrodes and cover patches every day.The area was clean with soap and water and alcohol wipes.The patient was using the aloe vera to refresh the area.The patient is allergic to iodine, sofran and adhesive.No seasonal allergies, patient does not have sensitive skin.The patient's skin is not irritated now, she is no longer using the cover patches and changing the electrodes daily.No further consequences have been reported.The product was not returned for evaluation.

• Brand Name: BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
• Common Device Name: ELECTRODE COVER PATCHES
• 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: 17720808
• Report Number: 0002242816-2023-00098
• Device Sequence Number: 20623894
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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,Followup
• Report Date (Section B): 02/25/2026

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 Expiration Date: 05/10/2025
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 218902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 04/04/2024; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic