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

Model Number	106130-17
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 by the patient indicates that she is severely allergic to the electrodes.She cannot wear them.The skin is so broken now.The patient needs replacements and possibly advice on what to do about the skin issue.The patient inquired if there was a different electrode.The patient stated that the skin irritation started a month ago.She took them off for about 10 days.The patient put them back on for 12 hours and the skin was red with bumps and itchy with little lesions and it leaked a clear liquid.The patient used the cover patches is what started the skin irritation.The electrodes were changed every day.They were moved around a little.The area was clean with soap and water, with no wipes.The patient does not have sensitive skin.The patient is allergic to latex.She has no other allergies or seasonal allergies.The patient spoke to her doctor who advised her to wear hydrocortisone cream once the skin is not broken and to take benadryl for the itchiness.The patient was told to use the electrodes for 10 days.That is when the second allergic reaction started.The patient took off the electrodes.She was advised to do the time test with the 63b electrodes once her skin is healed.No additional information has been received at this time.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore 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 patient indicates that she is severely allergic to the electrodes.She cannot wear them.The skin is so broken now.The patient needs replacements and possibly advice on what to do about the skin issue.The patient inquired if there was a different electrode.The patient stated that the skin irritation started a month ago.She took them off for about 10 days.The patient put them back on for 12 hours and the skin was red with bumps and itchy with little lesions and it leaked a clear liquid.The patient used the cover patches is what started the skin irritation.The electrodes were changed every day.They were moved around a little.The area was clean with soap and water, with no wipes.The patient does not have sensitive skin.The patient is allergic to latex.She has no other allergies or seasonal allergies.The patient spoke to her doctor who advised her to wear hydrocortisone cream once the skin is not broken and to take benadryl for the itchiness.The patient was told to use the electrodes for 10 days.That is when the second allergic reaction started.The patient took off the electrodes.She was advised to do the time test with the 63b electrodes once her skin is healed.No additional information has been received at this time.
Additional Manufacturer Narrative
Corrections - b2, b4: date of this report added, b5: updated the product was not returned for evaluation, d3: manufacturer address and email address, g1: contact office and manufacturer site, g2, g3, g6: report type.Additional information - h6: impact code, method, h10: additional narrative, h11.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 unable to be reviewed, as the lot number is unknown.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.
Additional Manufacturer Narrative
Udi related data quality updates only - a supplemental report is being submitted to address the discrepancies between fda medwatch form 3500a and gudid.Corrections: d1: brand name, d2a: device common name, d4: model number, d4: expiration date, g4: pma/510(k)#, h4: device manufacture date, h5: labeled for single use, h6: evaluation codes.Additional information: b4: date of this report, g3: date received by manufacturer.
Event or Problem Description
It was reported by the patient indicates that she is severely allergic to the electrodes.She cannot wear them.The skin is so broken now.The patient needs replacements and possibly advice on what to do about the skin issue.The patient inquired if there was a different electrode.The patient stated that the skin irritation started a month ago.She took them off for about 10 days.The patient put them back on for 12 hours and the skin was red with bumps and itchy with little lesions and it leaked a clear liquid.The patient used the cover patches is what started the skin irritation.The electrodes were changed every day.They were moved around a little.The area was clean with soap and water, with no wipes.The patient does not have sensitive skin.The patient is allergic to latex.She has no other allergies or seasonal allergies.The patient spoke to her doctor who advised her to wear hydrocortisone cream once the skin is not broken and to take benadryl for the itchiness.The patient was told to use the electrodes for 10 days.That is when the second allergic reaction started.The patient took off the electrodes.She was advised to do the time test with the 63b electrodes once her skin is healed.No additional information has been received at this time.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• 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: 18576658
• Report Number: 0002242816-2024-00012
• Device Sequence Number: 18371536
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 02/19/2026

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: 07/28/2025
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 225201
• 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; Not provided
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 06/20/2024; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic