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	Blister (4537); 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 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 she is getting a skin irritation from the 63b electrodes.The patient changes electrodes and rotates them every day.The patient did the time test and after the first hour she had a skin irritation.The skin was red and itchy and a red mark around the electrodes.The patient developed welts and blisters.The patient did not contact her doctor.The skin was clean with soap and water.The patient did not apply anything to the affected area.The patient stopped using the 63b electrodes around (b)(6) 2025.Later, the patient stated that the doctor advised to stop using the unit due to skin irritation with 63b electrodes.The patient advised she had an irritation to both types of electrodes.She spoke with her doctor and who said she can discontinue if she wants.The patient will conduct time-test using electrodes as advised by customer service representative.No further consequences were reported.63b electrodes were not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report,.Estimated date of the event b3: march 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 not reviewed.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.
Event or Problem Description
It was reported by the patient that she is getting a skin irritation from the 63b electrodes.The patient changes electrodes and rotates them every day.The patient did the time test and after the first hour she had a skin irritation.The skin was red and itchy and a red mark around the electrodes.The patient developed welts and blisters.The patient did not contact her doctor.The skin was clean with soap and water.The patient did not apply anything to the affected area.The patient stopped using the 63b electrodes around (b)(6) 2025.Later, the patient stated that the doctor advised to stop using the unit due to skin irritation with 63b electrodes.The patient advised she had an irritation to both types of electrodes.She spoke with her doctor and who said she can discontinue if she wants.The patient will conduct time-test using 72r electrodes as advised by customer service representative.No further consequences were reported.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: 22079962
• Report Number: 0002242816-2025-00074
• Device Sequence Number: 8702693
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/06/2025

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 Model Number: 106130-22
• 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: 05/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic