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

Model Number	1068238
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
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore 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 she experienced headaches and her wrist hurt while using her device.The pain started on the second day after she received her unit.The patient rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient stated the pain goes away after she stops wearing the unit.She advised she did not increase her daily activities.She called her doctor and had to leave a message.The patient states she has a fractured wrist and is taking pain medication for that.The customer service representative advised the patient to conduct a time test and increase the treatment time as tolerated.The patient agreed to call customer service back if there were any issues.No further consequences have been reported at this time.
Additional Manufacturer Narrative
Corrections - date of this report added, updated the product was not returned for evaluation, manufacturer address and email address, contact office and manufacturer site, report type, device code, impact code additional information - method.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 patient that she experienced headaches and her wrist hurt while using her device.The pain started on the second day after she received her unit.The patient rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient stated the pain goes away after she stops wearing the unit.She advised she did not increase her daily activities.She called her doctor and had to leave a message.The patient states she has a fractured wrist and is taking pain medication for that.The customer service representative advised the patient to conduct a time test and increase the treatment time as tolerated.The patient agreed to call customer service back if there were any issues.No further consequences have been reported at this time.No product was returned for evaluation.
Additional Manufacturer Narrative
Additional information: b4: date of this report, g3: date received by manufacturer: corrected data: a: date of birth, b2: outcomes attributed to adverse event, d1: brand name, d2: common device name, d4: model number, g4: premarket identification, h5: device labeled for single use, h6: evaluation codes.This follow-up report is being submitted to relay corrected information based on udi related data quality updates only.
Event or Problem Description
It was reported by the patient that she experienced headaches and her wrist hurt while using her device.The pain started on the second day after she received her unit.The patient rated the pain as an 8 on a scale of 1 to 10, with 10 being the highest.The patient stated the pain goes away after she stops wearing the unit.She advised she did not increase her daily activities.She called her doctor and had to leave a message.The patient states she has a fractured wrist and is taking pain medication for that.The customer service representative advised the patient to conduct a time test and increase the treatment time as tolerated.The patient agreed to call customer service back if there were any issues.No further consequences have been reported at this time.No product was returned for evaluation.

• 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: 17840005
• Report Number: 0002242816-2023-00105
• Device Sequence Number: 7390165
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/21/2025

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: 1068238
• Device Catalogue Number: 1068238
• 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; Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 06/19/2024; 08/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic