MAUDE Adverse Event Report: EBI, LLC. SFLX COILETTE; STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: non-invasive, bone growth stimulator.Medical product: sflx coilette.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient was experiencing pain while using the bhs device.The patient sated that she was unsure if the pain was caused by the bhs or not.The patient stated that the coil is painful to wear on certain parts of the foot.It is very sensitive to the touch.The patient wears a sock while using the stimulator.The pain started ever since she started using the stimulator.The patient just tolerated the pain.The patient rated the pain as a 8 or 9 on a scale of 1 to 10, with 10 being the highest.The pain is on the surface of the skin.The pain subsides after a while when she is not using the unit.The patient stated that she does not experience any pain while using the bhs at night.The patient has increased her daily activity.The patient has not seen the doctor for a month and he is not aware that she is having pain.No additional patient consequences have been reported.
Event or Problem Description
It was reported that the patient was experiencing pain while using the bhs device.The patient sated that she was unsure if the pain was caused by the bhs or not.The patient stated that the coil is painful to wear on certain parts of the foot.It is very sensitive to the touch.The patient wears a sock while using the stimulator.The pain started ever since she started using the stimulator.The patient just tolerated the pain.The patient rated the pain as a 8 or 9 on a scale of 1 to 10, with 10 being the highest.The pain is on the surface of the skin.The pain subsides after a while when she is not using the unit.The patient stated that she does not experience any pain while using the bhs at night.The patient has increased her daily activity.The patient has not seen the doctor for a month and he is not aware that she is having pain.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in d4, d8-9, d10 g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative 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 reviewed, and 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 for trend.

• Brand Name: SFLX COILETTE
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)
• 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: michael salvati ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 11256428
• Report Number: 0002242816-2021-00009
• Device Sequence Number: 3711242
• Product Code: LOF
• UDI-Device Identifier: 00812301020607
• UDI-Public: 00812301020607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 1068238
• Device Lot Number: 20265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2021
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE NARRATIVE IN H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic