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

Model Number	106130-20
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the sales representative that the patient indicated the unit gave horrible constant muscle contractions.Additionally, the patient mentioned that she has always had spasms on her back since surgery.However, she said when she wears the stimulator, it increases her spasms times 10.The patient was advised to try and do a slow roll out with the stimulator and slowly add an hour each day.No further consequences were reported.The 72r electrodes were not returned.
Additional Manufacturer Narrative
B4 event date: estimated date of event is may 2025.Without a product return, no product evaluation is able to be conducted.The device history records were reviewed and no discrepancies were found.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.Relevant mfr number: 0002242816-2025-00078.
Additional Manufacturer Narrative
B3 event date: estimated date of event is may 2025.Additional information: g3: date received by manufacturer, h6: evaluation codes.Corrected data: b2: outcomes attributed to adverse event, d2: common device name and product code, d4: serial number, this follow-up report is being submitted to relay additional and corrected information.The device was not returned to ebi 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.The device is used for treatment.Related manufacturer's report: mfr # 0002242816-2025-00078.
Event or Problem Description
It was reported by the sales representative that the patient indicated the unit gave horrible constant muscle contractions.Additionally the patient mentioned that she has always had spasms on her back since surgery.However she said when she wears the stimulator, it increases her spasms times 10.The patient was advised to try and do a slow roll out with the stimulator and slowly add an hour each day.No further consequences were reported.The 72r electrodes were not returned.

• 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: 22177279
• Report Number: 0002242816-2025-00079
• Device Sequence Number: 7818610
• Product Code: GXY
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• 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): 10/19/2025

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: 04/29/2026
• Device Model Number: 106130-20
• Device Lot Number: 25A110
• 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: 06/10/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic