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

Model Number	1067718
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: the date of the event is unknown and is estimated to have occurred in november of 2025 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
The patient reported experiencing stabbing, sharp pain when she treats with the orthopak.The patient was advised to remove the electrodes and only use the unit from 30 minutes to 2 hours.The doctor submitted a new rx for the patient to switch to a bhs device to see if the patient can tolerate this treatment.No further information was provided.
Event or Problem Description
The patient reported experiencing stabbing, sharp pain when she treats with the orthopak.The patient was advised to remove the electrodes and only use the unit from 30 minutes to 2 hours.The doctor submitted a new rx for the patient to switch to a bhs device to see if the patient can tolerate this treatment.No further information was provided.
Additional Manufacturer Narrative
Additional information: b4- date of this report, g3- date received by manufacturer, h2- follow up type corrected data: d1-brand name, d4 ¿ model number, catalog number, serial number this follow-up report is being submitted to relay additional and corrected information.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.The device is used for treatment.Ebi will continue to monitor trends.
Event or Problem Description
The patient reported experiencing stabbing, sharp pain when she treats with the orthopak.The patient was advised to remove the electrodes and only use the unit from 30 minutes to 2 hours.The doctor submitted a new rx for the patient to switch to a bhs device to see if the patient can tolerate this treatment.No further information was provided.
Additional Manufacturer Narrative
Additional information- b4: date of this report, g3: date received by manufacturer, h6: evaluation codes.Corrected data ¿h6: impact code (4642 and 4641 added).This follow-up report is being submitted to relay additional and corrected information.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.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.The device is used for treatment.Ebi will continue to monitor trends.

• Brand Name: BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
• 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: 23597308
• Report Number: 0002242816-2025-00147
• Device Sequence Number: 10477520
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• 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,Followup
• Report Date (Section B): 04/27/2026

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: 1067718
• Device Catalogue Number: 1067718
• 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: 11/19/2025
• Supplement Report FDA Received Date: 03/25/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic