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

Model Number	1068226
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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 is feeling discomfort while wearing her bhs unit with sflx coil 2.The customer service representative called the patient regarding the complaint.The patient stated that the first day she was having pain stabbing pain while she was on her leg.The patient wore it for 3 days straight with pain.The patient did not contact her doctor.The coil is not too tight.The pain is below skin.The pain level is between 8-10.She took tylenol.The pain does not go away when she is not wearing the unit.The patient has some pain when not using the stimulator but as soon as she wears it, pain increases.The patient has not increased her daily activity.The patient will conduct a time test.No further consequences are reported.The bhs controller and sflx-2 coil were not returned for further 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.
Event or Problem Description
It was reported by the sales representative that the patient is feeling discomfort while wearing her bhs unit with sflx coil 2.The customer service representative called the patient regarding the complaint.The patient stated that the first day she was having pain stabbing pain while she was on her leg.The patient wore it for 3 days straight with pain.The patient did not contact her doctor.The coil is not too tight.The pain is below skin.The pain level is between 8-10.She took tylenol.The pain does not go away when she is not wearing the unit.The patient has some pain when not using the stimulator but as soon as she wears it, pain increases.The patient has not increased her daily activity.The patient will conduct a time test.No further consequences are reported.The bhs controller and sflx-2 coil were not returned for further evaluation.
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 trends.
Additional Manufacturer Narrative
Additional information in following fields - b2: required intervention, b4: date of this report, b5: additional narrative, d9: return to manufacturer, g3: date received by manufacturer, h2, h6: impact code, method and results, h1: additional narrative.Corrected data in following fields - d2: common device name, d4: catalog number, h6: device code.A visual inspection of the customer returned product was performed.Included was one sflx 2 coil part no.1068226 with a missing julian date.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx 2 coil could not be reviewed as the julian date was missing.The sflx 2 coil was tested and it operates as intended.Test/inspections were completed by the quality department on june 19, 2025.The failure was not confirmed for the reported condition of "bhs unit caused pain".Review of complaint history identified (5) total complaints from (dec 30, 2023) to (dec 30, 2024) for pn (1068226) and events related to (pain).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "pain".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.
Event or Problem Description
It was reported by the sales representative that the patient is feeling discomfort while wearing her bhs unit with sflx coil 2.The customer service representative called the patient regarding the complaint.The patient stated that the first day she was having pain stabbing pain while she was on her leg.The patient wore it for 3 days straight with pain.The patient did not contact her doctor.The coil is not too tight.The pain is below skin.The pain level is between 8-10.She took tylenol.The pain does not go away when she is not wearing the unit.The patient has some pain when not using the stimulator but as soon as she wears it, pain increases.The patient has not increased her daily activity.The patient will conduct a time test.It was later reported that the patient continued to experience pain and had to take pain pills to conduct the time test.The patient stated that their doctor is aware of the pain and stated that the doctor said that it could be because she has a lot of screws on the fracture.The patient rated the pain level a 6 or 7 when treating with the device and a 4 or 5 when not treating.The patient was averaging 6 to 7 hours of treatment per day.It was later reported that the patient discontinued use of the bhs and received a new prescription for the orthopak due to the pain.No further information was provided.

• 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: 21232952
• Report Number: 0002242816-2025-00015
• Device Sequence Number: 8629936
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

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: 1068226
• Device Catalogue Number: 1068226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/14/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic