MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; STIMULATOR, BONE GROWTH, NON-INVASIVE

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
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
It was reported by the patient that her skin became very red and itchy while using 72r electrodes and cover patches.The patient changed them every day and rotated at that time.She wears them on her lower back.The patient is not sure if the irritation was coming from the tape that was on her wound.She spoke with her doctor, and he gave her medication for the itching.The patient states she does have sensitive skin.The customer service representative advised the patient to pause treatment until her skin clears.The patient was sent replacement 63b electrodes.No further consequences have been reported at this time.
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
It was reported by the patient that her skin became very red and itchy while using 72r electrodes and cover patches.The patient changed them every day and rotated at that time.She wears them on her lower back.The patient is not sure if the irritation was coming from the tape that was on her wound.She spoke with her doctor, and he gave her medication for the itching.The patient states she does have sensitive skin.The customer service representative advised the patient to pause treatment until her skin clears.The patient was sent replacement 63b electrodes.No further consequences have been reported at this time.The product was not returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and corrected information based on udi related data quality updates.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.The 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.Corrections: d1: brand name, d2a: device common name,d4: model number, g4: pma number, h6 product and evaluation codes.Additional information: a: patient information, e: initial reporter.
Event or Problem Description
It was reported by the patient that her skin became very red and itchy while using 72r electrodes and cover patches.The patient changed them every day and rotated at that time.She wears them on her lower back.The patient is not sure if the irritation was coming from the tape that was on her wound.She spoke with her doctor, and he gave her medication for the itching.The patient states she does have sensitive skin.The customer service representative advised the patient to pause treatment until her skin clears.The patient was sent replacement 63b electrodes.No further consequences have been reported at this time.The product was not returned.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• 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: 17737921
• Report Number: 0002242816-2023-00102
• Device Sequence Number: 5472614
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• 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): 10/21/2025

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 Expiration Date: 11/27/2025
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 218925
• 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; Not provided
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 03/29/2024; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2022
• 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.; SEE H10 NARRATIVE.
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic