MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; ELECTRODES, 63B, SPINALPAK/ORTHOPAK

Model Number	106130-22
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.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 that the patient had skin irritation with the 63b electrodes.The patient stated that the irritation is not bad and if it happens, she pauses for a couple days and then continues treating as she is committed to finishing her treatment regardless of any irritation.Customer service called the patient and found that the patient has very sensitive skin.The 63b electrodes are not as bad as the 72r electrodes.The patient has been moving and changing the electrodes daily.The patient does not currently have a reaction but every time the reaction occurs, she blisters and sometimes has open wounds.The patient is not using cover patches.Customer service advised the patient to change and rotate her electrodes twice daily.
Event or Problem Description
It was reported that the patient had skin irritation with the 63b electrodes.The patient stated that the irritation is not bad and if it happens, she pauses for a couple days and then continues treating as she is committed to finishing her treatment regardless of any irritation.Customer service called the patient and found that the patient has very sensitive skin.The 63b electrodes are not as bad as the 72r electrodes.The patient has been moving and changing the electrodes daily.The patient does not currently have a reaction but every time the reaction occurs, she blisters and sometimes has open wounds.The patient is not using cover patches.Customer service advised the patient to change and rotate her electrodes twice daily.
Additional Manufacturer Narrative
Corrected information - a: dob, d1: brand name, d2: common device name, d4: model number, h5, g4: premarket identification additional information- b4: date of this report, d4: lot number, expiration date, g3: date received by manufacturer, h2, h4: device manufacture date, h6: method, results, conclusions this follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge 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 trends.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODES, 63B, SPINALPAK/ORTHOPAK
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 19744353
• Report Number: 0002242816-2024-00089
• Device Sequence Number: 7991374
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/05/2024

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 Expiration Date: 02/28/2025
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 310501
• 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: 07/15/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic