MAUDE Adverse Event Report: EBI, LLC. SFLX 2 COIL

Model Number	N/A
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
Event or Problem Description
It was reported by the patient that she experienced a shock while treating with the bone healing system.The patient stated that the sflx 2 coil is giving her a shock when she wears it.The patient rated the pain as an 8 on a scale of 1 to 10, which is considered severe.There are no exposed nor cracked wires on the coil.The device was not dropped or in contact with any liquid.The patient advised that her ankle is still tender.The patient did not speak to a doctor regarding the issue.The patient will return the old coil.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer 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 trends.
Event or Problem Description
It was reported by the patient that she experienced a shock while treating with the bone healing system.The patient stated that the sflx 2 coil is giving her a shock when she wears it.The patient rated the pain as an 8 on a scale of 1 to 10, which is considered severe.There are no exposed nor cracked wires on the coil.The device was not dropped or in contact with any liquid.The patient advised that her ankle is still tender.The patient did not speak to a doctor regarding the issue.The patient will return the old coil.No additional patient consequences have been reported.No product was returned for evaluation.

• Brand Name: SFLX 2 COIL
• Common Device Name: 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15289332
• Report Number: 0002242816-2022-00099
• Device Sequence Number: 17968871
• Product Code: LOF
• UDI-Device Identifier: 00812301020515
• UDI-Public: 00812301020515
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/18/2024

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: 1068226
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic