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

Model Number	1068240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Dizziness (2194); Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation can 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 that the patient started to feel some internal tremors around the same time she started using the device.The patient was treating 10 hours per day every day.The patient experienced intermittent tremors both with the device on and when not wearing the device.There was no pain associated with the sensation.The patient was afraid to put the device back on as she does not want the tremors to return.The patient stated the sensation is similar to sitting on a vibrating pager, but she does not hear any vibration from the device.The vibrating sensation spreads from her foot up to her chest.No issues with the chest and above.The vibrating sensation makes her a bit dizzy when walking around.The patient is wearing the coil on her left foot.The patient has brittle bones in her lower spin and is unsure if that may be related to the issue.The patient has an appointment with her spinal doctor on (b)(6) 2024.The patient¿s scans are showing good healing and her foot feels much better so she does want to continue treating, but is afraid the bones in her back may be affected.It was later reported that the patient went to the cleveland spine clinic and was advised to discontinue use of the device.The doctors were unsure if the symptoms were related to the device but suggested she stop treating as a precaution since the symptoms started around the same time as the patient started treatment with the device.The patient mentioned that she was also experiencing lower back pain in l2, l3, l4, and l5.The patient experienced back pain prior to treating with the device but the pain got worse after treating with the bhs.The pain level is generally 9 out of 10.The patient has been to the hospital twice for pain since beginning treatment.The pain and tremors are not tied to any movements or time of day.The patient described the pain as cyclical and stated it ebbs and flows.The patient alternates between ice, heat, tylenol, and advil to treat the back pain depending on what works for her on any given day.The patient stated that her spine doctors are planning a joint injection to treat the pain.The patient confirmed that she has not treated with the device again.
Event or Problem Description
It was reported that the patient started to feel some internal tremors around the same time she started using the device.The patient was treating 10 hours per day every day.The patient experienced intermittent tremors both with the device on and when not wearing the device.There was no pain associated with the sensation.The patient was afraid to put the device back on as she does not want the tremors to return.The patient stated the sensation is similar to sitting on a vibrating pager, but she does not hear any vibration from the device.The vibrating sensation spreads from her foot up to her chest.No issues with the chest and above.The vibrating sensation makes her a bit dizzy when walking around.The patient is wearing the coil on her left foot.The patient has brittle bones in her lower spin and is unsure if that may be related to the issue.The patient has an appointment with her spinal doctor on (b)(6) 2024.The patient¿s scans are showing good healing and her foot feels much better so she does want to continue treating but is afraid the bones in her back may be affected.It was later reported that the patient went to (b)(6) and was advised to discontinue use of the device.The doctors were unsure if the symptoms were related to the device but suggested she stop treating as a precaution since the symptoms started around the same time as the patient started treatment with the device.The patient mentioned that she was also experiencing lower back pain in l2, l3, l4, and l5.The patient experienced back pain prior to treating with the device but the pain got worse after treating with the bhs.The pain level is generally 9 out of 10.The patient has been to the hospital twice for pain since beginning treatment.The pain and tremors are not tied to any movements or time of day.The patient described the pain as cyclical and stated it ebbs and flows.The patient alternates between ice, heat, tylenol, and advil to treat the back pain depending on what works for her on any given day.The patient stated that her spine doctors are planning a joint injection to treat the pain.The patient confirmed that she has not treated with the device again.No additional patient consequences/ further information has been reported.The sflx-xl coilette was not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b2: required medical intervention.Additional information in g3, h6 and h10: additional narrative.B4: date of the event- the estimated date of the event is november 2024.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.Without a product return, no product evaluation can be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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 trend.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Common Device Name: SFLX - XL COILETTE
• 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: 21136881
• Report Number: 0002242816-2025-00001
• Device Sequence Number: 7677343
• Product Code: LOF
• UDI-Device Identifier: 00812301020621
• UDI-Public: 00812301020621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/17/2025

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
• Device Catalogue 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: 01/13/2025
• Supplement Report FDA Received Date: 04/18/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic