MAUDE Adverse Event Report: EBI, LLC. SPF PLUS MINI 60 UAM; SPF-PLUS 60M IMPLANTABLE SPINAL FUSION STIMULATOR

Model Number	10-1398M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the unit implanted is listed on the 2018 recall.The patient states that he experienced horrific pain after the unit was implanted.The unit was explanted about 6 months later and alleviated some pain but not all.He has experienced pain, muscle spasms, infections, and utis for 8 years.He has received dry needling therapy for his muscle spasms.Long needles are stuck deep into the muscles that are spasming.The patient mentioned he does develop infections and uti after the dry needling therapy.He is unable to have an mri because there is a partial wire.The wires may have been cut vs disconnected.No additional information has been reported.Our research and development department stated that the spf shouldn't cause any utis.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Corrections in b4: date of the report, d1: brand name, d2a: device common name, d3: manufacturer, d4: model number, g1: contact office, g6: type of report, h2, h8, h5: labeled for single use.Additional information in d4, g3, h6: investigation type, findings, and conclusions and h10: additional narrative.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 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.Highridge medical will continue to monitor trends.
Event or Problem Description
It was reported that the unit implanted is listed on the 2018 recall.The patient states that he experienced horrific pain after the unit was implanted.The unit was explanted about 6 months later and alleviated some pain but not all.He has experienced pain, muscle spasms, infections, and utis for 8 years.He has received dry needling therapy for his muscle spasms.Long needles are stuck deep into the muscles that are spasming.The patient mentioned he does develop infections and uti after the dry needling therapy.He is unable to have an mri because there is a partial wire.The wires may have been cut vs disconnected.No additional information has been reported.Our research and development department stated that the spf shouldn¿t cause any utis.No additional patient consequences/ further information has been reported.The spf- plus mini was not returned for further evaluation.

• Brand Name: SPF PLUS MINI 60 UAM
• Common Device Name: SPF-PLUS 60M IMPLANTABLE SPINAL FUSION STIMULATOR
• 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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 19600578
• Report Number: 0002242816-2024-00082
• Device Sequence Number: 15505249
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P850035
• 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): 12/03/2024

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: 05/05/2018
• Device Model Number: 10-1398M
• Device Catalogue Number: 10-1398M
• Device Lot Number: 577-16
• 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: 06/24/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2016
• 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: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic