MAUDE Adverse Event Report: EBI, LLC. SPF PLUS MINI 60 UAM; STIMULATOR, INVASIVE BONE GROWTH

Model Number	10-1398M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient via the zimmer biomet complaints mailbox that the spf malfunctioned.The patient stated the unit that was placed on (b)(6) 2021 that malfunctioned with fusion not taking place.This lack of fusion and malfunction of the bone growth stimulator caused pain and misery with additional surgery on (b)(6) 2024 where the unit was removed.No further consequences were reported.There is no indication of device return for further evaluation.
Additional Manufacturer Narrative
Age at the time of event is unknown.Without a product return, no product evaluation is able to be conducted.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 via the zimmer biomet complaints mailbox that the spf malfunctioned.The patient stated that the fusion never took and screws were loose suggesting malfunction of the bone growth stimulator resulting in continued, sometimes severe, pain.The patient also stated that it resulted in spine and posture becoming bent over, both titled to the left and forward.The patient had to use a walker and underwent a major revision surgery (b)(6) 2024 with triple fusion where it did not take at l4-l5 as well as placement of iliac bolts to straighten the spine, plus removal of the stimulator.The patient stated that the pain and suffering from this has been profound no further consequences were reported.The patient declined to provide additional information.There is no indication of device return for further evaluation.
Additional Manufacturer Narrative
Section b3: date of the event is unknown.Additional information: b4: date of this report, b5: additional narrative, d4: expiration date, g3: date received by manufacturer, h4: device manufacture date, h6: evaluation codes.This follow-up report is being submitted to relay additional 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.

• Brand Name: SPF PLUS MINI 60 UAM
• Common Device Name: STIMULATOR, INVASIVE BONE GROWTH
• 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: 22319189
• Report Number: 0002242816-2025-00087
• Device Sequence Number: 12969315
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P850035
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 12/31/2025

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: Other
• Device Expiration Date: 02/25/2023
• Device Model Number: 10-1398M
• 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: 06/24/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic