MAUDE Adverse Event Report: EBI, LLC. SFLX 3 COIL; STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); 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) 2020.Medical product: implant used: depuy revision ankle nal 10 x 15cm proximal and distal locks.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 bone healing system (bhs).The patient has not been able to use the device without it causing her pain.The doctor wanted the patient to switch to a different device for treatment and requested to convert her to an orthopak device.No additional patient consequences have been reported.
Event or Problem Description
It was reported that the patient was experiencing pain while using the bone healing system (bhs).The patient has not been able to use the device without it causing her pain.The doctor wanted the patient to switch to a different device for treatment and requested to convert her to an orthopak device.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The device was not returned to zimmer biomet 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.Zimmer biomet will continue to monitor for trends.The following sections have been updated: b4: date of this report added.D9: device availability added.G1: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type updated.H3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: type of device code updated to 2993: adverse event without identified device or use problem.H6: type of investigation updated to 4114: device not returned.H6: type of investigation updated to 4119: insufficient information available.H6: investigation findings updated to 3221: no findings available.H6: investigation conclusions updated to 4315: cause not established.

• Brand Name: SFLX 3 COIL
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 10898172
• Report Number: 0002242816-2020-00126
• Device Sequence Number: 1336772
• Product Code: LOF
• UDI-Device Identifier: 00812301020546
• UDI-Public: 00812301020546
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P790002/S026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: N/A
• Device Catalogue Number: 1068229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 07/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female