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

Model Number	1068238
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.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.Section b3: as the day of the event is unknown, the event date is estimated as march of 2025.
Event or Problem Description
It was reported by the patient that the velcro on the sflx coilette has worn out, patient also stated that it hurts when they walk.The sflx coilette is too fat and causes a lot of pain while walking.No further consequences are reported.There was no product returned for further evaluation.
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as march of 2025.Additional information in following fields - b4: date of this report, d4: lot number, d9: returned to manufacturer date, g3: date received by manufacturer, h4: device manufacture date, h6: evaluation codes.Corrected data in following fields - d2: common device name.A visual inspection of the customer returned product was performed.Included was one sflx coilette part no.1068238 with julian date 25056.The part appeared to be in good condition from the cosmetic/visual point of view.The dhr for the sflx coilette was reviewed and there were no reports of non-conformances or deviations.The sflx coilette was tested and it operates as intended.Review of complaint history identified (2) total complaints from (march 20, 2024) to (march 20, 2025) for part number (1068238) 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 patient that the velcro on the sflx coilette has worn out, patient also stated that it hurts when they walk.The sflx coilette is too fat and causes a lot of pain while walking.No further consequences are reported.

• 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: 21843250
• Report Number: 0002242816-2025-00055
• Device Sequence Number: 8698919
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• 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): 07/31/2025

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
• Device Lot Number: 25056
• 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
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2025
• 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: 88 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic