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	Rash (2033); 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 by the sales representative that the patient has issues with the electrodes.The customer service representative called the patient and found that both 72r and 63b electrodes caused an irritation and the 63b were the worst.She used the cover patches with the electrodes and has a sensitivity to adhesives.The customer service representative advised the patient to stop wearing the unit and contact her doctor and update what they advised.Later, as per complaint specialist, the patient stated that they developed red, itchy skin with tiny blisters and no swelling while using the 72r and 63b electrodes.The patient did not change or rotate the electrodes for 3 days until the skin irritation got worst.The patient contacted their physician who advised to stop wearing the unit and prescribed otc cream and vitamin d supplements.The patient also stated that they are allergic to latex and glue/adhesives.The patient stated that the cover patches also caused skin irritation and it ripped off her skin as she's allergic to adhesives.The electrodes and cover patches made the skin irritation worst all together.No further information has been reported.The 63b electrodes has not been returned for evaluation.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d7.Additional information in d4: expiration date, g3, h6: investigation type and h10: additional narrative.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 trends.
Event or Problem Description
It was reported by the sales representative that the patient has issues with the electrodes.The customer service representative called the patient and found that both 72r and 63b electrodes caused an irritation and the 63b were the worst.She used the cover patches with the electrodes and has a sensitivity to adhesives.The customer service representative advised the patient to stop wearing the unit and contact her doctor and update what they advised.Later, as per complaint specialist, the patient stated that they developed red, itchy skin with tiny blisters and no swelling while using the 72r and 63b electrodes.The patient did not change or rotate the electrodes for 3 days until the skin irritation got worst.The patient contacted their physician who advised to stop wearing the unit and prescribed otc cream and vitamin d supplements.The patient also stated that they are allergic to latex and glue/adhesives.The patient stated that the cover patches also caused skin irritation and it ripped off her skin as she's allergic to adhesives.The electrodes and cover patches made the skin irritation worst all together.No further information has been reported.The 63b electrodes has not been returned for evaluation.

• 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: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 20598758
• Report Number: 0002242816-2024-00138
• Device Sequence Number: 8943565
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/23/2025

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: 04/29/2026
• Device Model Number: 106130-22
• Device Lot Number: 412801
• 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: 11/04/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic