MAUDE Adverse Event Report: EBI, LLC. SPF®-PLUS-MINI (60 UA/M); STIMULATOR, INVASIVE BONE GROWTH

Model Number	10-1398M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Paralysis (1997); Sepsis (2067)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a: attempts have been made to obtain age/dob, however the information has not been provided.Section b3: month and day of the event are unknown.Estimated event date is 2025.Section h6 additional patient codes: 1754: bruise/contusion, 1848: fall, 1930: unspecified infection, 4895: back pain, 4401: balance problems.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.The device is used for treatment.Related report number: mw5176231.
Event or Problem Description
It was reported that the patient went to the emergency room after tripping and falling.The first few days after the fall the patient experienced pain and had bruises to the hands, wrists, and knees.Three to five days after the fall, the patient¿s symptoms spiked.The patient experienced a paralyzing effect on everything from the torso down through the legs.The patient¿s hand-eye coordination was off, and the patient had zero balance.The patient stated that they had never experienced anything so painful.The patient was later hospitalized for a septic infection that they feel the spinal stimulator could have contributed to.The patient is unsure of the source of the infection and is question whether the implant shifted after the fall and caused the infection.No further information was provided.
Additional Manufacturer Narrative
Additional information - b4: date of this report, d3: email address, d4: expiration date, g1: email address, g3: date received by manufacturer, h4: device manufacture date, h6: investigation type, findings, and conclusions and h10: additional narrative.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.Ebi will continue to monitor trends.
Event or Problem Description
It was reported that the patient went to the emergency room after tripping and falling.The first few days after the fall the patient experienced pain and had bruises to the hands, wrists, and knees.Three to five days after the fall, the patient¿s symptoms spiked.The patient experienced a paralyzing effect on everything from the torso down through the legs.The patient¿s hand-eye coordination was off, and the patient had zero balance.The patient stated that they had never experienced anything so painful.The patient was later hospitalized for a septic infection that they feel the spinal stimulator could have contributed to.The patient is unsure of the source of the infection and is question whether the implant shifted after the fall and caused the infection.No further information was provided.

• Brand Name: SPF®-PLUS-MINI (60 UA/M)
• 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: 23477337
• Report Number: 0002242816-2025-00139
• Device Sequence Number: 16060078
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2023
• 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): 04/13/2026

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: 03/29/2025
• Device Model Number: 10-1398M
• Device Catalogue Number: 10-1398M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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: Hospitalization
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White