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

Model Number	106130-22
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
Event or Problem Description
It was reported by the product surveillance specialist that the patient indicated that they developed rash/irritation while using replacement 63b electrodes.The patient indicated that they were experiencing irritation with 63b electrodes.The patient did not contact their doctor or did not use any ointment/ creams on the affected area.The customer service representative advised the patient to clean the area with soap and water and conduct a time-test after the skin heals completely.Later, the customer service representative called the patient regarding skin irritation and had to leave a voicemail.Later, the patient called back and stated that she waited for two weeks for her skin to heal after the issue with 72r electrodes before using 63b electrodes.After one hour of using 63b electrodes, the patient developed rash, hives like allergy and skin was red, itchy.Her skin is very sensitive to all adhesives including paper tape and ekg electrodes.She also has eczema.The patient had not used any ointment on the area and did speak to her doctor.The doctor suggested she contact the sales representative if he can help with any alternative electrodes and the doctor would speak to representative about another product that does not have electrodes.The patient was concerned about losing valuable treatment plan and agreed to do try time test again at 30 mins interval for several days and if tolerated she may up the treatment time by 45 mins and so on.The patient will update sales rep on how the time-test went but still feels that this is not the correct device for her needs due to severe skin allergies.As per the sales representative, the doctor wants the patient to immediately end her use with spinalpak due to allergies and requested a return label for the unit.No further consequences are reported.The 63b electrodes were not returned for further evaluation.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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
Section a: patient information.Corrected data: b3: date of event, g1: first name, last name, and email address.Additional information: b4: date of this report, d4: expiration date, g3: date received by manufacturer, h4: device manufacture date, h6: evaluation codes.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical 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.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.Ebi will continue to monitor for trends.
Event or Problem Description
It was reported by the product surveillance specialist that the patient indicated that they developed rash/irritation while using replacement 63b electrodes.The patient indicated that they were experiencing irritation with 63b electrodes.The patient did not contact their doctor or did not use any ointment/ creams on the affected area.The customer service representative advised the patient to clean the area with soap and water and conduct a time-test after the skin heals completely.Later, the customer service representative called the patient regarding skin irritation and had to leave a voicemail.Later, the patient called back and stated that she waited for two weeks for her skin to heal after the issue with 72r electrodes before using 63b electrodes.After one hour of using 63b electrodes, the patient developed rash, hives like allergy and skin was red, itchy.Her skin is very sensitive to all adhesives including paper tape and ekg electrodes.She also has eczema.The patient had not used any ointment on the area and did speak to her doctor.The doctor suggested she contact the sales representative if he can help with any alternative electrodes and the doctor would speak to representative about another product that does not have electrodes.The patient was concerned about losing valuable treatment plan and agreed to do try time test again at 30 mins interval for several days and if tolerated she may up the treatment time by 45mins and so on.The patient will update sales rep on how the time-test went but still feels that this is not the correct device for her needs due to severe skin allergies.As per the sales representative, the doctor wants the patient to immediately end her use with spinalpak due to allergies and requested a return label for the unit.No further consequences are reported.The 63b electrodes were not returned for further evaluation.

• 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: 21595520
• Report Number: 0002242816-2025-00038
• Device Sequence Number: 8349878
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/12/2025

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: 03/30/2026
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 433701
• 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
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/31/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic