MAUDE Adverse Event Report: EBI, LLC. ORTHOPAK ASSEMBLY; ORTHOPAK NONINVASIVE BONE GROWTH STIMULATOR

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales rep that the patient started feeling an aching pain in her muscles.She thought it may be from the opak, so she stopped use, and the pain subsided.She then started using the opak again, and the pain returned after treating for 4 days.The patient was advised to stop use again.The patient's doctor advised them to take a couple of days off to take a break.She was advised to cut her time in half and wear the unit every other day to see if that helps.The patient has not had muscle pain since.
Additional Manufacturer Narrative
(b)(4).Date of event: (b)(6) 2021.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.
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.The following sections have been updated: b4: date of this report added.D3: manufacturer updated.G1: contact office updated.G3: date received by manufacturer added.G6: type of report updated.H2: follow up type added.H3: device evaluated by manufacturer updated to no.H6: impact code 4649 - unanticipated adverse device effect.H6: clinical code 1994 - pain.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.H6: investigation conclusion added 4315 - cause not established.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.
Event or Problem Description
It was reported by the sales rep that the patient started feeling an aching pain in her muscles.She thought it may be from the opak, so she stopped use, and the pain subsided.She then started using the opak again, and the pain returned after treating for 4 days.The patient was advised to stop use again.The patient's doctor advised them to take a couple of days off to take a break.She was advised to cut her time in half and wear the unit every other day to see if that helps.The patient has not had muscle pain since.

• Brand Name: ORTHOPAK ASSEMBLY
• Common Device Name: ORTHOPAK NONINVASIVE BONE GROWTH 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: 12816718
• Report Number: 0002242816-2021-00199
• Device Sequence Number: 17817704
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/11/2023

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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