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

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
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.
Event or Problem Description
It was reported by the patient that he has a lot of pain while using the orthopak on the left shoulder.The patient stated that the pain started within an hour of using the orthopak and is is below the skin.According to the patient, the pain is radiating to the neck and down the arm.The patient reported that the pain level is an 8 out of 10.The patient has not increased his daily activities.The patient stated he called the doctor spoke to the pa who told the patient to contact our company.The patient reported that the doctor did not prescribe anything, but he is taking advil for the pain.The patient reported that he removed the orthopak about 3 hours ago and the pain is subsiding very slowly.Ana maria lepiani told the patient to wait a couple of days then start using the unit doing the time test.The patient was asked to please give us a call back on the 3rd or 4th day to let us know how he is feeling.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device not was 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 by the patient that he has a lot of pain while using the orthopak on the left shoulder.The patient stated that the pain started within an hour of using the orthopak and is below the skin.According to the patient, the pain is radiating to the neck and down the arm.The patient reported that the pain level is an 8 out of 10.The patient has not increased his daily activities.The patient stated he called the doctor and spoke to the pa who told the patient to contact our company.The patient reported that the doctor did not prescribe anything, but he is taking advil for the pain.The patient reported that he removed the orthopak about 3 hours ago and the pain is subsiding very slowly.Ana maria lepiani told the patient to wait a couple of days then start using the unit doing the time test.The patient was asked to please give us a call back on the 3rd or 4th day to let us know how he is feeling.No additional patient consequences have been reported.It was later reported was reported by the sales rep that the patient cannot tolerate the electrodes and the surgeon would like to switch him to the exogen but is willing to try the bhs.The sales rep reported this is due to the same injury previously.

• Brand Name: ORTHOPAK ASSEMBLY
• Common Device Name: ORTHOPAK PAK NON-INVASIVE STIMULATOR
• 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: 15902363
• Report Number: 0002242816-2022-00148
• Device Sequence Number: 12029916
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 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: 10/12/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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