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 in (b)(6) 2020.Medical product: synthes posterolateral condylar plate.Medical product: synthes medial condylar plate.Medical product: synthes 7.3 cannulated screw.Medical product:18 gauge wire.Medical product: locking and nonlocking screws.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 excruciating pain from the bone healing system (bhs).The patient stated that he used the device for the first day and with in minutes he had excruciating pain.The patient rated the pain level as a 10 on a scale from 1 to 10, with 10 being the highest.The patient says that the pain subsides within an hour.The patient took ibuprofen 800 mg.The patient stated that he used it the next day with the same results.He believes that the unit is not helping him and he is very grateful but he does not want.No new product was shipped to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device was not returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with pain.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.
Event or Problem Description
It was reported that the patient was experiencing excruciating pain from the bone healing system (bhs).The patient stated that he used the device for the first day and with in minutes he had excruciating pain.The patient rated the pain level as a 10 on a scale from 1 to 10, with 10 being the highest.The patient says that the pain subsides within an hour.The patient took ibuprofen 800 mg.The patient stated that he used it the next day with the same results.He believes that the unit is not helping him and he is very grateful but he does not want.No new product was shipped to the patient.

• Brand Name: SFLX 3 COIL
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 11041968
• Report Number: 0002242816-2020-00136
• Device Sequence Number: 1307934
• Product Code: LOF
• UDI-Device Identifier: 00812301020546
• UDI-Public: 00812301020546
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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
• Device Lot Number: N/A
• 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: 11/19/2020
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 05/09/2023
• 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: Male