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

Model Number	1068240
Medical Device Problem Code	Insufficient Device Problem Information (3190)
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 she had extreme pain while using bhs unit and sflx-xl coilette.The pain was at 8-10 on a scale of 1-10, 10 being the worst.The patient stated that she pulled off her sock and ripped the coil off her foot as soon as she woke up.Once coil was removed pain subsided.The patient did not contact her doctor nor took any medications.The coil was making a humming/ clicking sound.No further consequences are reported.The bhs controller and sflx-xl coilette were not returned for further evaluation.
Additional Manufacturer Narrative
Estimated date of the event b3: december 2024.This follow-up report is being submitted to relay additional and corrected information.The sflx-xl coilette 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 not reviewed as coil was not returned and lot number could not be verified.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.Reference to related mfr number: (b)(4).
Event or Problem Description
It was reported by the patient that she had extreme pain while using bhs unit and sflx-xl coilette.The pain was at 8-10 on a scale of 1-10, 10 being the worst.The patient stated that she pulled off her sock and ripped the coil off her foot as soon as she woke up.Once coil was removed pain subsided.The patient did not contact her doctor nor took any medications.The coil was making a humming/ clicking sound.No further consequences are reported.The bhs controller and sflx-xl coilette were not returned for further evaluation.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM SFLX- XL COILETTE
• 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: 20990071
• Report Number: 0002242816-2024-00165
• Device Sequence Number: 12709782
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 1068240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 05/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic