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

Model Number	1068234
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
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 by the patient that he is in pain.It feels like a needle inside.It is a burning pain and the pain level is way over 10.The skin is red.The skin is slightly warmer than the rest of his body.On wednesday it looked like red dots.Today it looks very red on the area.The patient started about 2 months ago.The patient did mention this to his doctor and the doctor told him this was the healing process.The pain is only when he is wearing the unit.When he takes it off the pain diminishes and goes away after an hour or so.The area that is red gets irritated when he is wearing his shoes.The customer service representative offered to replace his unit and coil and the patient declined saying he does not want to delay the healing.He also wanted to review the placement of the coil.The customer service representative advised she would have his sales representative robyn rosen call him regarding this issue.The customer service representative called robyn rosen and explained the patient's issue.She advised not to send any new product as she will contact the patient and advise him to visit the doctor.Robyn noted this may be a new medical issue since there was no pain for over a month of treating between (b)(6) 2025 and (b)(6) 2026.No product was shipped.No return noted.
Additional Manufacturer Narrative
Additional information: b4- date of this report, g3- date received by manufacturer, h6- evaluation codes.Corrected data: h5: corrected to yes, labeled for single use.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.
Event or Problem Description
It was reported by the patient that he is in pain.It feels like a needle inside.It is a burning pain and the pain level is way over 10.The skin is red.The skin is slightly warmer than the rest of his body.On wednesday it looked like red dots.Today it looks very red on the area.The patient started about 2 months ago.The patient did mention this to his doctor and the doctor told him this was the healing process.The pain is only when he is wearing the unit.When he takes it off the pain diminishes and goes away after an hour or so.The area that is red gets irritated when he is wearing his shoes.The customer service representative offered to replace his unit and coil and the patient declined saying he does not want to delay the healing.He also wanted to review the placement of the coil.The customer service representative advised she would have his sales representative (b)(6) call him regarding this issue.The customer service representative called (b)(6) and explained the patient's issue.She advised not to send any new product as she will contact the patient and advise him to visit the doctor.(b)(6) noted this may be a new medical issue since there was no pain for over a month of treating between (b)(6) 2025 and (b)(6) 2026.No product was shipped.No return noted.
Event or Problem Description
It was reported by the patient that he is in pain.It feels like a needle inside.It is a burning pain and the pain level is way over 10.The skin is red.The skin is slightly warmer than the rest of his body.On wednesday it looked like red dots.Today it looks very red on the area.The patient started about 2 months ago.The patient did mention this to his doctor and the doctor told him this was the healing process.The pain is only when he is wearing the unit.When he takes it off the pain diminishes and goes away after an hour or so.The area that is red gets irritated when he is wearing his shoes.The customer service representative offered to replace his unit and coil and the patient declined saying he does not want to delay the healing.He also wanted to review the placement of the coil.The customer service representative advised she would have his sales representative robyn rosen call him regarding this issue.The customer service representative called robyn rosen and explained the patient's issue.She advised not to send any new product as she will contact the patient and advise him to visit the doctor.Robyn noted this may be a new medical issue since there was no pain for over a month of treating between (b)(6) 25 and(b)(6) 26.No product was shipped.No return noted.
Additional Manufacturer Narrative
Additional information- b4: date of this report, h6: evaluation codes corrected data: d3: manufacturer email address, g1: contact office email address this follow-up report is being submitted to relay additional 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 EBI BONE HEALING 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: 24344003
• Report Number: 0002242816-2026-00014
• Device Sequence Number: 18560503
• Product Code: LOF
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P790002
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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: 1068234
• Device Catalogue Number: 1068234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: 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: 02/16/2026
• Supplement Report FDA Received Date: 03/25/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Unknown