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

Model Number	106130-22
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); 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 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 that the patient who stated that she is itching with the 63b electrodes.The skin is red and itchy.The patient wants to continue treatment.The patient is allergic to adhesive and latex.The patient did not speak to her doctor the area is clean with soap and water.The patient changes her electrodes every day.The patient has not applied anything to the affected area.The patient requested 63b electrodes and cover patches.I did remind the patient that the cover patches has adhesive.The patient stated that she wants to continue using the device.No further consequences have been reported at this time.
Event or Problem Description
It was reported that the patient who stated that she is itching with the 63b electrodes.The skin is red and itchy.The patient wants to continue treatment.The patient is allergic to adhesive and latex.The patient did not speak to her doctor the area is clean with soap and water.The patient changes her electrodes every day.The patient has not applied anything to the affected area.The patient requested 63b electrodes and cover patches.I did remind the patient that the cover patches has adhesive.The patient stated that she wants to continue using the device.No further consequences have been reported at this time.Mdr report #: mw5153574.Reporter calling, stating she had spinal surgery in her neck on (b)(6) 2024, and was discharged two days later, on (b)(6) 2024.Reporter states that upon discharge she was instructed to use a biomet orthopak bone growth stimulator for six months.Reporter states she wears the device every day, as instructed, but has been having problems.Reporter states the included electrodes cause her skin to itch and they are "too adhesive" and cause constant skin irritation.Reporter states there was also a problem with the battery that was only recently discovered.Reporter states as a result she has been wearing the device for two months however recently learned that the device wasn't working during this time.Reporter states she has concerns about her healing and recovery process after her spinal neck surgery, and fears that lack of treatment these past two months has put her recovery behind.Reporter states a new device is being sent to her but it has not yet arrived.Additionally, reporter states she will be following up with her surgeon's office regarding her concerns about recovery and the healing process.Reporter states she feels this device has been detrimental to her health.
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.
Additional Manufacturer Narrative
Additional information- g1: contact office, h4: device manufacture date, h6: method, results, conclusions correction: g3: date received by manufacturer.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.
Event or Problem Description
It was reported that the patient who stated that she is itching with the 63b electrodes.The skin is red and itchy.The patient wants to continue treatment.The patient is allergic to adhesive and latex.The patient did not speak to her doctor the area is clean with soap and water.The patient changes her electrodes every day.The patient has not applied anything to the affected area.The patient requested 63b electrodes and cover patches.I did remind the patient that the cover patches has adhesive.The patient stated that she wants to continue using the device.No further consequences have been reported at this time.Mdr report #: mw5153574 reporter calling, stating she had spinal surgery in her neck on (b)(6) 2024, and was discharged two days later, on (b)(6) 2024.Reporter states that upon discharge she was instructed to use a biomet orthopak bone growth stimulator for six months.Reporter states she wears the device every day, as instructed, but has been having problems.Reporter states the included electrodes cause her skin to itch and they are "too adhesive" and cause constant skin irritation.Reporter states there was also a problem with the battery that was only recently discovered.Reporter states as a result she has been wearing the device for two months however recently learned that the device wasn't working during this time.Reporter states she has concerns about her healing and recovery process after her spinal neck surgery, and fears that lack of treatment these past two months has put her recovery behind.Reporter states a new device is being sent to her but it has not yet arrived.Additionally, reporter states she will be following up with her surgeon's office regarding her concerns about recovery and the healing process.Reporter states she feels this device has been detrimental to her health.
Event or Problem Description
It was reported that the patient who stated that she is itching with the 63b electrodes.The skin is red and itchy.The patient wants to continue treatment.The patient is allergic to adhesive and latex.The patient did not speak to her doctor the area is clean with soap and water.The patient changes her electrodes every day.The patient has not applied anything to the affected area.The patient requested 63b electrodes and cover patches.I did remind the patient that the cover patches has adhesive.The patient stated that she wants to continue using the device.No further consequences have been reported at this time.Mdr report #: mw5153574.Reporter calling, stating she had spinal surgery in her neck on (b)(6) 2024, and was discharged two days later, on (b)(6) 2024.Reporter states that upon discharge she was instructed to use a biomet orthopak bone growth stimulator for six months.Reporter states she wears the device every day, as instructed but has been having problems.Reporter states the included electrodes cause her skin to itch and they are "too adhesive" and cause constant skin irritation.Reporter states there was also, a problem with the battery that was only recently discovered.Reporter states as a result she has been wearing the device for two months however recently learned that the device wasn't working during this time.Reporter states she has concerns about her healing and recovery process after her spinal neck surgery, and fears that lack of treatment these past two months has put her recovery behind.Reporter states a new device is being sent to her but it has not yet arrived.Additionally, reporter states she will be following up with her surgeon's office regarding her concerns about recovery and the healing process.Reporter states she feels this device has been detrimental to her health.
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.

• Brand Name: BIOMET SPINALPAK / ORTHOPAK
• Common Device Name: ELECTRODE, CUTANEOUS
• 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: 19226210
• Report Number: 0002242816-2024-00061
• Device Sequence Number: 8473529
• Product Code: GXY
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,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: 03/01/2025
• Device Model Number: 106130-22
• Device Catalogue Number: 106130-22
• Device Lot Number: 310501
• 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; Not provided
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/09/2024; 09/13/2024; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• 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: 83 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic