MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM SFLX-2 THERAPEUTIC TREATMENT COIL; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number	1068226
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 stating that his bhs device (sflx 2 coil) is making his fracture and elbow hurt worse after treatment.The patient treats for 7 hours per day and has no issue while treating but after the device is turned off.He states that 15 minutes later he has sharp pain.The patient rates the pain level an 8 out of 10.The patient claims most days since his injury he is at a two all day long.The patient¿s doctor is prescribing pain management for his continuous pain.The patient has completed physical therapy.He sometimes overexerts himself by lifting things that are too heavy or using his injured arm to lean on to stand up after sitting on the floor.He also claims his doctor has told him not to do these things and to rest his arm all day.Zimvie customer service representative advised to pause treatment for a couple days then perform a time test and gradually work his way back to 7 hours per day if tolerated.The patient agreed.No further consequence have been reported at this time.
Additional Manufacturer Narrative
Corrections - b2, b4: date of this report added, b5: updated the product was not returned for evaluation, d3: manufacturer address and email address, g1: contact office and manufacturer site, g3, g6: report type, h6: device code and 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 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 stating that his bhs device (sflx 2 coil) is making his fracture and elbow hurt worse after treatment.The patient treats for 7 hours per day and has no issue while treating but after the device is turned off.He states that 15 minutes later he has sharp pain.The patient rates the pain level an 8 out of 10.The patient claims most days since his injury he is at a two all day long.The patient¿s doctor is prescribing pain management for his continuous pain.The patient has completed physical therapy.He sometimes overexerts himself by lifting things that are too heavy or using his injured arm to lean on to stand up after sitting on the floor.He also claims his doctor has told him not to do these things and to rest his arm all day.Zimvie customer service representative advised to pause treatment for a couple days then perform a time test and gradually work his way back to 7 hours per day if tolerated.The patient agreed.No further consequence have been reported at this time.
Additional Manufacturer Narrative
Corrections -b4: date of this report added,d1: brand name, d2a: device common name, d4: model number, g4: pma number, h5: labelled for single use, h6: evaluation code.Additional information - g3: date received by manufacturer, h10: additional narrative d4: lot number is unknown (unk) as the product was not returned.Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies between fda medwatch form 3500a and gudid.
Event or Problem Description
It was reported by the patient stating that his bhs device (sflx 2 coil) is making his fracture and elbow hurt worse after treatment.The patient treats for 7 hours per day and has no issue while treating but after the device is turned off.He states that 15 minutes later he has sharp pain.The patient rates the pain level an 8 out of 10.The patient claims most days since his injury he is at a two all day long.The patient¿s doctor is prescribing pain management for his continuous pain.The patient has completed physical therapy.He sometimes overexerts himself by lifting things that are too heavy or using his injured arm to lean on to stand up after sitting on the floor.He also claims his doctor has told him not to do these things and to rest his arm all day.Zimvie customer service representative advised to pause treatment for a couple days then perform a time test and gradually work his way back to 7 hours per day if tolerated.The patient agreed.No further consequence have been reported at this time.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM SFLX-2 THERAPEUTIC TREATMENT COIL
• 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: 18150445
• Report Number: 0002242816-2023-00125
• Device Sequence Number: 20486433
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• 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,Followup
• Report Date (Section B): 09/02/2025

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: 1068226
• Device Catalogue Number: 1068226
• 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; Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 06/21/2024; 09/03/2025
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic