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 Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an allergic reaction to the 63b electrodes.The patient stated that he was in the process of being switched to the bhs after discussing the issue with his sales representative.It was later reported that the patient decided to pause treatment due to the irritation and is waiting until his november appointment with his doctor to get a second opinion.No further information was provided.
Additional Manufacturer Narrative
Section d4: the expiration date is unknown as the device history record (dhr) has bas been requested but not yet provided.Section h4: the manufacturing date is unknown as the dhr has been requested but not yet provided.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.
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as september of 2024.Corrected data: b3: date of event, g1: first name, last name, and email address.Additional information: b4: date of this report, d4: expiration date, g3: date received by manufacturer, h4: device manufacture date, h6: evaluation codes 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.(b)(6) medical will continue to monitor for trends.
Event or Problem Description
It was reported that the patient had an allergic reaction to the 63b electrodes.The patient stated that he was in the process of being switched to the bhs after discussing the issue with his sales representative.It was later reported that the patient decided to pause treatment due to the irritation and is waiting until his november appointment with his doctor to get a second opinion.No further information was provided.It was later reported that the patient spoke with his surgeon on (b)(6)2024 and was told he did not need electrical stimulation.The surgeon did not think it was necessary.The patient stated that we would be discarding the remaining electrodes.No further information was provided.

• 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: 20545004
• Report Number: 0002242816-2024-00135
• Device Sequence Number: 7827962
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: 05/31/2026
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 419601
• 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: 10/28/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic