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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain with the ortho pak device.The patient does not feel pain while using the stimulator.The patient feels a little more pain than usual the day after the treatment, but she is not sure whether the pain is from the unit or from physical therapy.The last x-ray that was taken last week had shown bone healing.The pain is below the skin.The patient told her the doctor about the pain and was advised to continue using the device.The patient stated that her right arm is broken, and she is having a hard time putting the unit on.The patient rated the pain as a 4 on a scale of 1 to 10, with 10 being the highest.The patient has increased her daily activity.The patient is having physical therapy.The doctor is happy that she has the device.The doctor prescribed hydrocodone with acetaminophen.The patient sometimes takes the prescribed medication or will take tylenol over the counter.The patient mentioned she had a skin rash for about a week but then it went away.However, the patient did not want to speak about the rash.The patient was not sent a replacement product.No further consequences have been reported.
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 followup report will be sent.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in d4, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.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.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported that the patient experienced pain with the ortho pak device.The patient does not feel pain while using the stimulator.The patient feels a little more pain than usual the day after the treatment, but she is not sure whether the pain is from the unit or from physical therapy.The last x-ray that was taken last week had shown bone healing.The pain is below the skin.The patient told her the doctor about the pain and was advised to continue using the device.The patient stated that her right arm is broken, and she is having a hard time putting the unit on.The patient rated the pain as a 4 on a scale of 1 to 10, with 10 being the highest.The patient has increased her daily activity.The patient is having physical therapy.The doctor is happy that she has the device.The doctor prescribed hydrocodone with acetaminophen.The patient sometimes takes the prescribed medication or will take tylenol over the counter.The patient mentioned she had a skin rash for about a week but then it went away.However, the patient did not want to speak about the rash.The patient was not sent a replacement product.No further consequences have been reported.No additional patient consequences have been reported.Orthopak was not returned for further evaluation.
Additional Manufacturer Narrative
Corrections: d1: brand name, d2a: device common name, d3: manufacturer, d4: model number, g4: pma number, h6 product and evaluation codes.This follow-up report is being submitted to relay corrected information based on udi related data quality updates only.
Event or Problem Description
It was reported that the patient experienced pain with the ortho pak device.The patient does not feel pain while using the stimulator.The patient feels a little more pain than usual the day after the treatment, but she is not sure whether the pain is from the unit or from physical therapy.The last x-ray that was taken last week had shown bone healing.The pain is below the skin.The patient told her the doctor about the pain and was advised to continue using the device.The patient stated that her right arm is broken, and she is having a hard time putting the unit on.The patient rated the pain as a 4 on a scale of 1 to 10, with 10 being the highest.The patient has increased her daily activity.The patient is having physical therapy.The doctor is happy that she has the device.The doctor prescribed hydrocodone with acetaminophen.The patient sometimes takes the prescribed medication or will take tylenol over the counter.The patient mentioned she had a skin rash for about a week but then it went away.However, the patient did not want to speak about the rash.The patient was not sent a replacement product.No further consequences have been reported.No additional patient consequences have been reported.Orthopak was not returned for further evaluation.

• 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: 17652190
• Report Number: 0002242816-2023-00095
• Device Sequence Number: 6257192
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/05/2025

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: 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: 08/30/2023
• Supplement Report FDA Received Date: 06/07/2024; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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.; SEE H10 NARRATIVE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic