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

Model Number	1068229
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 after an hour of wear time, the bhs causes extreme pain, and she can only wear it for an hour at a time.The orthopedic doctor told her to cut back to like 3 hours a day or break up into sessions.The patient saw the rheumatoid doctor and he told her the setting could be adjusted and to call.The patient was upset at the hassle.The patient was told by the sales representative they would reach out to a team member.The sales representative wanted to check if the bhs could be switched to an opak device.No additional information has been received at this time.
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.D3 added suite (b)(4).
Event or Problem Description
It was reported by the patient that after an hour of wear time, the bhs causes extreme pain, and she can only wear it for an hour at a time.The orthopedic doctor told her to cut back to like 3 hours a day or break up into sessions.The patient saw the rheumatoid doctor and he told her the setting could be adjusted and to call.The patient was upset at the hassle.The patient was told by the sales representative they would reach out to a team member.The sales representative wanted to check if the bhs could be switched to an opak device.No additional information has been received at this time.It was later reported by the patient that when she wears the unit, the pain is in her left hand.The patient is having pain within an hour to two hours.The patient is treating the forearm.The patient stated that she compares the pain to nerve pain or carpal tunnel pain.The pain level started at a 2 or 3 out of 10 and it would build up and after a few hours, the patient will take it off.The patient treats with the device approximately 5 hours a day.The patient has seen her surgeon.The patient takes off the unit when the pain level is at an 8.
Additional Manufacturer Narrative
Corrections - b4: date of this report added, d3: manufacturer address and email address, g1: contact office and manufacturer site, g3, g6: report type, h6: device code, impact code additional information - h6: method, h10: additional narrative, h11.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 lot 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 by the patient that after an hour of wear time, the bhs causes extreme pain, and she can only wear it for an hour at a time.The orthopedic doctor told her to cut back to like 3 hours a day or break up into sessions.The patient saw the rheumatoid doctor and he told her the setting could be adjusted and to call.The patient was upset at the hassle.The patient was told by the sales representative they would reach out to a team member.The sales representative wanted to check if the bhs could be switched to an opak device.No additional information has been received at this time.It was later reported by the patient that when she wears the unit, the pain is in her left hand.The patient is having pain within an hour to two hours.The patient is treating the forearm.The patient stated that she compares the pain to nerve pain or carpal tunnel pain.The pain level started at a 2 or 3 out of 10 and it would build up and after a few hours, the patient will take it off.The patient treats with the device approximately 5 hours a day.The patient has seen her surgeon.The patient takes off the unit when the pain level is at an 8.
Event or Problem Description
It was reported by the patient that after an hour of wear time, the bhs causes extreme pain, and she can only wear it for an hour at a time.The orthopedic doctor told her to cut back to like 3 hours a day or break up into sessions.The patient saw the rheumatoid doctor and he told her the setting could be adjusted and to call.The patient was upset at the hassle.The patient was told by the sales representative they would reach out to a team member.The sales representative wanted to check if the bhs could be switched to an opak device.No additional information has been received at this time.It was later reported by the patient that when she wears the unit, the pain is in her left hand.The patient is having pain within an hour to two hours.The patient is treating the forearm.The patient stated that she compares the pain to nerve pain or carpal tunnel pain.The pain level started at a 2 or 3 out of 10 and it would build up and after a few hours, the patient will take it off.The patient treats with the device approximately 5 hours a day.The patient has seen her surgeon.The patient takes off the unit when the pain level is at an 8.
Additional Manufacturer Narrative
Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies between fda medwatch form 3500a and gudid.Corrections: d1: brand name, d2a: device common name, d4: model number, d4: expiration date, g4: pma/510(k)#, h4: device manufacture date, h5: labeled for single use, h6: evaluation codes.Additional information: b4: date of this report, g3: date received by manufacturer.

• 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: 18707909
• Report Number: 0002242816-2024-00019
• Device Sequence Number: 8508507
• Product Code: LOF
• UDI-Device Identifier: 00812301020546
• UDI-Public: 00812301020546
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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,Followup
• Report Date (Section B): 01/30/2026

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: 1068229
• Device Catalogue Number: 1068229
• 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; Not provided
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/18/2024; 06/25/2024; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic