MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK / ORTHOPAK; ELECTRODE COVER PATCHES

Model Number	106130-17
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient woke up with a severe burning pain on her neck.The patient mentioned that the cover patches were irritating her skin.It was later reported that the patient¿s skin was raised and very red around the cover patches.The patient woke up and felt like ¿her neck was on fire¿ and noted the area was puffy.The irritation remained for three days.The patient stated that she had a hard time removing the cover patches but was able to do so with adhesive spray.This was the first time the patient experienced an irritation with the cover patches.The patient did not speak to her doctor.The patient rated the pain level as an 8 out of 10.The patient noted that she is only allergic to seafood and is not taking blood pressure medication.No further information was provided.
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.
Additional Manufacturer Narrative
Additional information in following fields- b4: date of this report, b5: additional narrative, d4: lot number and expiration date, g3: date received by manufacturer, h2, h6: evaluation codes.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.
Event or Problem Description
It was reported that the patient woke up with a severe burning pain on her neck.The patient mentioned that the cover patches were irritating her skin.It was later reported that the patient¿s skin was raised and very red around the cover patches.The patient woke up and felt like ¿her neck was on fire¿ and noted the area was puffy.The irritation remained for three days.The patient stated that she had a hard time removing the cover patches but was able to do so with adhesive spray.This was the first time the patient experienced an irritation with the cover patches.The patient did not speak to her doctor.The patient rated the pain level as an 8 out of 10.The patient noted that she is only allergic to seafood and is not taking blood pressure medication.No further information was provided.It was later reported that the patient believes the reaction was due to a lotion she was using as she had the same reaction elsewhere on her body.The patient requested an additional supply of cover patches.No further information was provided.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODE COVER PATCHES
• 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: 21147994
• Report Number: 0002242816-2025-00010
• Device Sequence Number: 9236573
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• 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): 06/05/2025

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: 09/29/2025
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 306984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic