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	Erythema (1840); 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.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 a rash and skin irritation with the 63b electrodes.Sometimes the irritation is around the electrodes and other times it is underneath the electrodes.It was later reported that the patient¿s skin irritation consisted of a rash and redness, no blisters or welts.The patient contacted a tele-health doctor for the skin irritation and was prescribed a steroid ointment for the rash.The patient stated that the skin irritation was much better after using the ointment.The doctor advised to use vaseline for skin dryness and itchiness.The patient noted that she is using the electrodes on her middle to lower back.The patient was unsure if the rash was caused by only the 63b electrodes or something else.The patient requested additional 63b electrodes to continue treatment.No further information was provided.
Event or Problem Description
It was reported that the patient experienced a rash and skin irritation with the 63b electrodes.Sometimes the irritation is around the electrodes and other times it is underneath the electrodes.It was later reported that the patient¿s skin irritation consisted of a rash and redness, no blisters or welts.The patient contacted a tele-health doctor for the skin irritation and was prescribed a steroid ointment for the rash.The patient stated that the skin irritation was much better after using the ointment.The doctor advised to use vaseline for skin dryness and itchiness.The patient noted that she is using the electrodes on her middle to lower back.The patient was unsure if the rash was caused by only the 63b electrodes or something else.No further information was provided.63b electrodes were not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d2: common name, g4: pma number.Additional information in a2: age at the time of event, b5: event description, g3, h6 and h10: additional narrative.Estimated date of the event b3: january 2025 this follow-up report is being submitted to relay additional and corrected information.The 63b electrodes were 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.Highridge medical will continue to monitor trends.

• 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: 21265804
• Report Number: 0002242816-2025-00021
• Device Sequence Number: 4275998
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/30/2025

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: 05/31/2026
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 419601
• 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
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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: Initial
• 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: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic