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

Model Number	10-1318
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that the device stopped functioning approximately six months after implantation.The patient stated that the device had been recalled and expressed concerns regarding the availability of records and assistance related to the implant.The patient referenced osteogen, a tibial fracture, her coccyx, and concerns that the implant had moved within her body.The patient reported being unable to obtain device removal and stated that healthcare providers had only offered pain management.The patient stated that she was given pain killers.The patient indicated an intent to pursue legal action.The patient was informed that, if the referenced device was the product in question, its intended therapeutic activity duration is approximately 24 weeks and that removal may be performed by a physician when clinically indicated.The call ended before additional information could be obtained.No further information was provided.
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as 1998.D4: the serial number of the device is unknown.Attempts have been made for additional information, however, no further information was provided.D6a: as the day and month of the implant are unknown, the implant date is estimated as 1998.H4: as the device serial number is unknown, the date of manufacture could not be determined.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 follow-up report will be sent.

• 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: 25614372
• Report Number: 0002242816-2026-00079
• Device Sequence Number: 10438533
• Product Code: LOE
• UDI-Device Identifier: 00812301020010
• UDI-Public: 00812301020010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: Lay User/Patient
• Device Model Number: 10-1318
• Device Catalogue Number: 10-1318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• 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: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic