MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; ELECTRODE, CUTANEOUS

Model Number	106130-20
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records were able 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 advised that the 72r electrodes are causing a skin irritation in the cervical area.The skin irritation started a couple of months ago.The skin is red, itchy, causing blisters and welts.The electrodes and cover patches are changed and moved around every day.The area is cleaned with soap and water, no wipes.The patient is using opzelura cream prescribed by his dermatologist for the irritation in the cervical area.The patient did go see the dermatologist for this issue, the surgeon was not aware of the irritation.The patient advised the sales rep that 72r electrodes are not sticking and causing a minor irritation, but no advice was given.The patient has no known allergies, the patient has seasonal allergies.63b electrodes and cover patches were shipped to the patient.
Event or Problem Description
The patient advised that the 72r electrodes are causing a skin irritation in the cervical area.The skin irritation started a couple of months ago.The skin is red, itchy, causing blisters and welts.The electrodes and cover patches are changed and moved around every day.The area is cleaned with soap and water, no wipes.The patient is using opzelura cream prescribed by his dermatologist for the irritation in the cervical area.The patient did go see the dermatologist for this issue; the surgeon was not aware of the irritation.The patient advised the sales rep that 72r electrodes are not sticking and causing a minor irritation, but no advice was given.The patient has no known allergies, the patient has seasonal allergies.63b electrodes and cover patches were shipped to the patient.
Additional Manufacturer Narrative
Additional information - b4: date of this report, d8: device available for evaluation, d9: returned to manufacturer date.G3: date received by manufacture.A visual inspection of the customer returned product was performed.Included was 1 pack of 72r electrodes part no.106130-20 with lot no.25b043 received in a shipping mailer cushion envelope.The parts received look to be in good condition from the visual/cosmetic view.The certificate of conformance was requested and reviewed in the product information section and there were no non-conformances or deviations reported.The 72r electrodes were received for evaluation.The certificate of conformance was reviewed in the product information section.All evaluation results are included in the summary section.Review of complaint history identified (b)(4) total complaints from (dec 10, 2024) to (dec 10, 2025) for pn (106130-20) and events related to (electrode irritation/rash).Keyword search criteria: (complaint codes: electrode: irritation, electrode: rash).The search was specified to the lot no.25b043.The search identified ((b)(4)) complaint.Review of the information provided by the customer and along with findings from the investigation, indicate there are no systemic issues with the product or lot.Therefore, the bill of materials (boms), material certifications, master labels, and product drawings were not requested or pulled during this investigation.The approved suppliers were not contacted, and the product was not pulled from stock for evaluation.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.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODE, CUTANEOUS
• 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: 24650165
• Report Number: 0002242816-2026-00158
• Device Sequence Number: 21305899
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 25B043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic