MAUDE Adverse Event Report: EBI, LLC. ORTHOPAK ASSEMBLY; ORTHO PAK NON-INVASIVE STIMULATOR

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
This report is being submitted to relay additional 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.Zimmer biomet complaint# (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.Therapy date: unknown.
Event or Problem Description
It was reported that the patient is experiencing pain within the treatment site after wearing the device.She has stopped using the device until the pain improves.The patient stated that the pain is on the left femur.The patient was having pain at a 1 out of 10 with medication and 5 out of 10 without medication.The patient has been receiving physical therapy to help her improve her mobility and balance (using her walker) but had to stop because she could not handle the pain and discomfort.It was later reported that the patient uses tramadol, gabapentin and tylenol as prescribed by the doctor.It was stated that the doctor recommended the patient continue treating for 4 to 8 hours a day instead of 24 hours a day.The patient is using the product for 1 to 3 hours a day instead of the hours recommended by the doctor depending on the discomfort she feels.The patient feels pain with or without using the unit but when she is using it her discomfort seems to be more.

• Brand Name: ORTHOPAK ASSEMBLY
• Common Device Name: ORTHO PAK NON-INVASIVE STIMULATOR
• 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: 13049302
• Report Number: 0002242816-2021-00236
• Device Sequence Number: 1427161
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• 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
• Report Date (Section B): 12/20/2021

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: 1067718
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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: Female