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

Model Number	1067718
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported by the patient that she experienced a cramp in her foot while treating with the orthopak device.The patient is treating her big toe.The patient rated the pain level an 8 out of 10, 10 being the highest.Usually when she turns the device off the cramps disappear.The patient stated that this discomfort began about one week after she started treating.And has been happening for about one month of treatments.The patient spoke with her foot doctor, who suggested that she contact us and had no other advice.The patient stated that she experienced pain from her foot to the calf while driving and was not treating with the device.The last time she treated before today's discomfort was yesterday before bedtime.The patient was advised to pause treatment until she had no discomfort.She can perform the time test and begin the test at 30 minutes per day for three days if she is comfortable, then add 30 minutes every 3 days.The patient agreed to call back with any issues.No further consequences have been reported at this time.
Event or Problem Description
It was reported by the patient that she is treating her big toe and when she treats, she has cramps in her foot that are an 8 out of 10 pain level.Usually when she turns the device off the cramps disappear.The patient stated that this discomfort began about one week after she started treating.And has been happening for about one month of treatments.The patient spoke with her foot doctor, and he suggested she call us and had no other advice.Today the patient was driving in her truck, and she had the cramps 8 out of 10 from her foot up her calf while she was not treating with the device and the last time she treated before today's discomfort was yesterday before bedtime.The patient regularly treats for two hours per day.The patient was advised to pause treatment until she had no discomfort and then perform the time test and begin the test at 30 minutes per day for three days then if she is comfortable, she can add 30 minutes every 3 days.The patient agreed to call back with any issues.No additional patient consequences/ further information has been reported.The orthopak unit was not returned for further evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer, d1: brand name, d2a: device common name, d3: manufacturer, d4: model number, d4: serial number, d4: expiration date, g1: contact office, g4: pma number, g6: type of report, h2, h8, h3, h4: device manufacture date, h5: labeled for single use.Additional information in d4, g3, h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to (b)(6) medical 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.Highridge medical will continue to monitor for trend.

• Brand Name: BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
• Common Device Name: ORTHOPAK ASSEMBLY
• 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: 19397908
• Report Number: 0002242816-2024-00069
• Device Sequence Number: 12459033
• Product Code: LOF
• UDI-Device Identifier: 00812301020232
• UDI-Public: 00812301020232
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: Lay User/Patient
• Device Model Number: 1067718
• Device Catalogue Number: 1067718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic