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

Model Number	106130-20
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed skin irritation on one side of her back from the 72r electrodes after about 10 days of treatment.The skin was red with a rash that had puss and blood as it oozed.The patient changed the electrodes daily and rotated the position.Only one section of the patient¿s back was irritated, not the other positions.The patient had a follow up visit with their doctor on (b)(6) 2025 and was advised that the irritation was infected.The doctor prescribed an oral antibiotic as the infection was getting worse and slowly growing larger than the shape of the electrode.The doctor also advised not to put any cream on the skin.The doctor advised to continue treatment and avoid the irritated section of the skin.It was later reported that the skin irritation had resolved as of (b)(6) 2025.No further information was provided.
Additional Manufacturer Narrative
Section b3: as the day of the event is unknown, the event date is estimated as july of 2025.Without a product return, no product evaluation is able to be conducted.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 developed skin irritation on one side of her back from the 72r electrodes after about 10 days of treatment.The skin was red with a rash that had puss and blood as it oozed.The patient changed the electrodes daily and rotated the position.Only one section of the patient¿s back was irritated, not the other positions.The patient had a follow up visit with their doctor on (b)(6) 2025 and was advised that the irritation was infected.The doctor prescribed an oral antibiotic as the infection was getting worse and slowly growing larger than the shape of the electrode.The doctor also advised not to put any cream on the skin.The doctor advised to continue treatment and avoid the irritated section of the skin.It was later reported that the skin irritation had resolved as of (b)(6) 2025.No further information was provided.
Additional Manufacturer Narrative
Additional information - b4: date of this report, d8: device available for evaluation, d9: returned to manufacturer date.G3: date received by manufacturer.A visual inspection of the customer returned product was performed.Included was 13 packs of 72r electrodes part no.106130-20 with lot no.25a111 received in a shipping mailer cushion envelope.The parts received look to be in good condition from the visual/cosmetic view.The certificate of conformance was requested and reviewed and there were no non-conformances or deviations reported.Review of complaint history identified 158 total complaints from (july 18, 2024) to (july 18, 2025) for pn (106130-20) and events related to (electrode irritation/rash).The search was specified to the lot no.25a111.The search identified (1) complaint.Review of complaint history identified 1 total complaint from (july 18, 2024) to (july 18, 2025) for pn (106130-20) and events related to (medical infection).The search was specified to the lot no.25a111.The search identified (1) complaint.Review of the information provided by the customer and along with findings from the investigation, indicate there are no systemic issues with the product or lot.Therefore, the bill of materials (boms), material certifications, master labels, and product drawings were not requested or pulled during this investigation.The approved suppliers were not contacted, and the product was not pulled from stock for evaluation.No physical and/or functional condition could be found after review of the certificate of conformance that could be considered a causal factor for the reported complaint.The reported claim could be associated with a side effect/clinical condition of the patient which is unknown.The reported condition is related to clinical factors beyond the scope of the device investigation covered in the complaint investigation as part of the manufacturing review.Therefore, no further actions are required at this time.Ebi will continue to monitor for trends.This device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

• 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: 22792545
• Report Number: 0002242816-2025-00097
• Device Sequence Number: 21019296
• Product Code: LOF
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• 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
• Report Date (Section B): 01/13/2026

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: Other
• Device Expiration Date: 05/30/2026
• Device Model Number: 106130-20
• Device Catalogue Number: 106130-20
• Device Lot Number: 25A111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/13/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic