MAUDE Adverse Event Report: EBI, LLC. EBI OSTEOGEN¿ IMPLANTABLE BONE GROWTH STIMULATOR; STIMULATOR, INVASIVE BONE GROWTH

Model Number	10-1320M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a: date of birth and age are unknown.Section d: the serial number has been requested but not yet provided.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 that the patient had a plate and the osteogen implanted in (b)(6) 2024.Since then, the patient has been in pain and has a burning sensation that at times is a 10 out of 10.It was noted that the patient had a knee replacement 10 years ago, and the patient¿s husband stated that the internal adhesive did not adhere.The rod was moving around and rubbing the patient¿s bone, thus ruining the bone.In (b)(6) 2024, the patient had surgery where the rod was removed and the knee was replaced again.6 months later, there was no improvement or bone growth, so the osteogen was implanted.The discomfort was reported to the patient¿s doctor and the doctor said she is still healing and was unable to diagnose where the patient¿s pain was coming from.The doctor recently did a 3-phase bone scan to diagnose the patient¿s issues, but the results had not come back yet.The patient¿s husband stated that he is not accusing the device of causing discomfort but rather trying to find answers and educate himself on his wife¿s issues.It was later reported that the patient¿s leg is also red and hot a lot of the time.The patient¿s husband only contacted customer service regarding possible side effects as the patient¿s doctor had not provided the information.No further information was provided.
Additional Manufacturer Narrative
Section a: date of birth and age are unknown.Section d: the serial number has been requested but not yet provided.Corrected data in the following fields - d2: common device name, g1: contact office first name, last name, and email address.Additional information in the following fields - b4: date of this report, h2, h6: method, results, and conclusions.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 unable to be reviewed as the serial number of the product is unknown.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 that the patient had a plate and the osteogen implanted in (b)(6) 2024.Since then, the patient has been in pain and has a burning sensation that at times is a 10 out of 10.It was noted that the patient had a knee replacement 10 years ago, and the patient¿s husband stated that the internal adhesive did not adhere.The rod was moving around and rubbing the patient¿s bone, thus ruining the bone.In (b)(6) 2024, the patient had surgery where the rod was removed and the knee was replaced again.6 months later, there was no improvement or bone growth, so the osteogen was implanted.The discomfort was reported to the patient¿s doctor and the doctor said she is still healing and was unable to diagnose where the patient¿s pain was coming from.The doctor recently did a 3-phase bone scan to diagnose the patient¿s issues, but the results had not come back yet.The patient¿s husband stated that he is not accusing the device of causing discomfort but rather trying to find answers and educate himself on his wife¿s issues.It was later reported that the patient¿s leg is also red and hot a lot of the time.The patient¿s husband only contacted customer service regarding possible side effects as the patient¿s doctor had not provided the information.No further information was provided.

• Brand Name: EBI OSTEOGEN¿ IMPLANTABLE BONE GROWTH STIMULATOR
• Common Device Name: STIMULATOR, INVASIVE BONE GROWTH
• 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: 21232708
• Report Number: 0002242816-2025-00013
• Device Sequence Number: 11834055
• Product Code: LOE
• UDI-Device Identifier: 00812301020034
• UDI-Public: 00812301020034
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P790005
• 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): 06/12/2025

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: 10-1320M
• Device Catalogue Number: 10-1320M
• 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: 01/24/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic