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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(6).B3: date of event: the event occurred sometime in may 2023.D11: medical product: unknown.D11: 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 wanted to return the device because he experienced pain and was not using it.The patient said the 1st doctor who prescribed the device screwed up and put the wrong rod in and the bone was rubbing which caused the pain.The patient had to go see another doctor who did his total knee replacement.That doctor performed the corrective surgery and did not tell him he had to use the device.Everything is healing fine now.
Event or Problem Description
It was reported by the patient that had pain while using the orthopak.No additional patient consequences have been reported.The orthopak assembly was returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in d4, d8-9, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.Investigation summary: the orthopak assembly was received for evaluation but due to the nature of the complaint and the information provided within the complaint file, only the orthopak stimulator was evaluated.A visual inspection of the customer returned product was performed.Included was one orthopak stimulator part no.1067718 with serial number (b)(6) received in a shipping box.The part received appears to be in good condition from the visual/cosmetic point of view.The dhr/coc has indicated no reported non-conformances or deviations.The failure was not confirmed for the reported condition of the "experienced pain".The unit was tested, and the unit stopped beeping when the dummy load was entered.The spinalpak was tested using battery burn-in-stand-alone test and checked clock lifetime.The results from the testing indicated no functional discrepancies.Review of the information provided by the customer and the findings from the investigation indicated that no physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint of "pain".No failure and/or fault condition could be found and confirmed.Therefore, no further actions are required at this time.Review of complaint history identified (13) total complaints from (may 31, 2022) to (may 31, 2023) for pn (1067718, 1067719) and events related to (pain).Keyword search criteria: (complaint code: medical: pain) the search could not be specified further because the main complaint was pain.Highridge medical will continue to monitor for trend.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• Brand Name: ORTHOPAK ASSEMBLY
• Common Device Name: STIMULATOR, ORTHOPAK, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17102131
• Report Number: 0002242816-2023-00070
• Device Sequence Number: 1932565
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• Exemption Number: 5645646
• 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,Followup
• Report Date (Section B): 06/18/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 1067718
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2023
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic