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
Additional Manufacturer Narrative
Zimvie complaint (b)(4).B3: date of event: the event occurred sometime on (b)(6), 2023.D11: medical product: unknown.D11: therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported by the patient that the cover patches are causing skin irritation in the lumbar area.The patient changes the patches every one to two days.The patient stated he would have to leave the electrodes and cover patches off for a few days.The skin causes bumps, similar to acne, it is only on his back, and there are no blisters.The patient stated he did go to his primary care physician and was prescribed steroid cream to use as needed.The patient has not used the cream yet, states the area is clean with water and soap, and alcohol after washing.The patient does not have sensitive skin nor does he have any allergies.The patient also stated the 72r electrodes do not stick to the skin, even using a drop of water does not help.The patient rotates the electrodes and the cover patches.63b electrodes and cover patches were shipped to the patient per the patient's request.Zimvie customer service representative told the patient to change the electrodes daily and not to use the cover patches.The 72r electrodes are not expected to be returned.
Event or Problem Description
It was reported by the patient that the cover patches are causing skin irritation in the lumbar area.The patient changes the patches every one to two days.The patient stated he would have to leave the electrodes and cover patches off for a few days.The skin causes bumps, similar to acne, it is only on his back, and there are no blisters.The patient stated he did go to his primary care physician and was prescribed steroid cream to use as needed.The patient has not used the cream yet, states the area is clean with water and soap, and alcohol after washing.The patient does not have sensitive skin nor does he have any allergies.The patient also stated the 72r electrodes do not stick to the skin, even using a drop of water does not help.The patient rotates the electrodes and the cover patches.63b electrodes and cover patches were shipped to the patient per the patient's request.Zimvie customer service representative told the patient to change the electrodes daily and not to use the cover patches.The 72r electrodes are not expected to be returned.The cover patches were not returned for evaluation.
Additional Manufacturer Narrative
Corrections - 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, 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 product was not returned and the lot number of the product 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 that the cover patches are causing skin irritation in the lumbar area.The patient changes the patches every one to two days.The patient stated he would have to leave the electrodes and cover patches off for a few days.The skin causes bumps, similar to acne, it is only on his back, and there are no blisters.The patient stated he did go to his primary care physician and was prescribed steroid cream to use as needed.The patient has not used the cream yet, states the area is clean with water and soap, and alcohol after washing.The patient does not have sensitive skin nor does he have any allergies.The patient also stated the 72r electrodes do not stick to the skin, even using a drop of water does not help.The patient rotates the electrodes and the cover patches.63b electrodes and cover patches were shipped to the patient per the patient's request.Zimvie customer service representative told the patient to change the electrodes daily and not to use the cover patches.The 72r electrodes are not expected to be returned.The cover patches were not returned for evaluation.

• 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: 17373488
• Report Number: 0002242816-2023-00081
• Device Sequence Number: 20598374
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 05/10/2025
• Device Model Number: 106130-17
• Device Catalogue Number: 106130-17
• Device Lot Number: 212627
• 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: 07/21/2023
• Supplement Report FDA Received Date: 06/07/2024; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2022
• 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: 36 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic