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	Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: as the onset date of the skin irritation is unknown, the event date is estimated as january of 2026.D4: lot number of the product is unknown.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
It was reported that the patient experienced skin irritation with the 72r electrodes.The skin irritation was on the lumbar area.The patient stated that the skin is red around the edge and it gets itchy by the end of the day.The patient changes the electrodes once per week but removes them every night.The electrodes are not moved around to different locations.The irritated area was cleaned with an alcohol pad.The patient applied benadryl cream for the itching.The patient was shipped alternate electrodes to try.It was later reported that the patient¿s doctor advised her to discontinue treatment at a follow up appointment.No further information was provided.
Event or Problem Description
It was reported that the patient experienced skin irritation with the 72r electrodes.The skin irritation was on the lumbar area.The patient stated that the skin is red around the edge and it gets itchy by the end of the day.The patient changes the electrodes once per week but removes them every night.The electrodes are not moved around to different locations.The irritated area was cleaned with an alcohol pad.The patient applied benadryl cream for the itching.The patient was shipped alternate electrodes to try.It was later reported that the patient¿s doctor advised her to discontinue treatment at a follow up appointment.No further information was provided.
Additional Manufacturer Narrative
Additional information- b4: date of this report, d4: lot number and expiration date, d8-9 returned to manufacturer date, g3: date received by manufacturer, h3, h4: device manufacture date, h6: evaluation codes a visual inspection of the customer returned product was performed.Included was one pack of 72r electrodes part no.106130-20 with lot no.25g021 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 reviewed and no non-conformances or deviations were reported.Review of complaint history identified 148 total complaints from (january 12, 2025) to (january 12, 2026) for pn (106130-20) and events related to (electrode irritation/rash).The search was specified to lot no.25g021.The search identified (1) 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.The device is used for treatment.Ebi will continue to monitor trends.

• 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: 24332726
• Report Number: 0002242816-2026-00013
• Device Sequence Number: 11965189
• Product Code: GXY
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/05/2026

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: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 25G021
• 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: 02/13/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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
• Patient Sex: Unknown