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

Model Number	1067718
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient experienced pain while using orthopak unit.Later, the patient was contacted again for additional information and stated that they have been wearing the device for too long and indicated that the pain was at 10 on a scale of 1-10.The patient contacted their physician but, the cause of the pain was not identified, and doctor did not prescribe any medications.The patient decided to conduct a time-test as advised by the sales representative and stated that the pain subsided with shorter treatment time.No further information has been reported.The orthopak unit has not been returned for 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
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 trends.
Event or Problem Description
It was reported by the sales representative that the patient experienced pain while using orthopak unit.Later, the patient was contacted again for additional information and stated that they have been wearing the device for too long and indicated that the pain was at 10 on a scale of 1-10.The patient contacted their physician but, the cause of the pain was not identified, and doctor did not prescribe any medications.The patient decided to conduct a time-test as advised by the sales representative and stated that the pain subsided with shorter treatment time.No further information has been reported.The orthopak unit has not been returned for evaluation.

• Brand Name: BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
• Common Device Name: ORTHOPAK ASSEMBLY
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 20224390
• Report Number: 0002242816-2024-00121
• Device Sequence Number: 7240086
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/12/2025

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 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
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic