MAUDE Adverse Event Report: EBI, LLC. SPF-XL IIB 2/DM

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2023.Medical product: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient's spf was explanted due to pain.The patient's implant date was (b)(6) 2022 at hmh bayshore medical center.The implanted spf was spf xl iib, 2/dm - 10-1335m, serial number (b)(6).Additional contact and demographic details on the patient are not available.Additional details on the patient's experience are not available.No replacements to our knowledge.The patient stated, "we believe the wire broke after a rear end mva about a year after implantation.My surgeon did take out the battery part of the time.But the cathodes are still in my cervical area.The patient stated that the issue is getting a facility to take an mri needed of my hip and elbow area.The patient was told to contact zimvie.The patient was not sent a replacement product.The product is not expected to be return.No additional information was provided at this time.
Event or Problem Description
It was reported that the patient's spf was explanted due to pain.The patient's implant date was on (b)(6) 2022 at (b)(6) medical center.The implanted spf was spf xl iib, 2/dm - 10-1335m, serial number (b)(6).Additional contact and demographic details on the patient are not available.Additional details on the patient's experience are not available.No replacements to our knowledge.The patient stated, "we believe the wire broke after a rear end mva about a year after implantation.My surgeon did take out the battery part of the time.But the cathodes are still in my cervical area.The patient stated that the issue is getting a facility to take an mri needed of my hip and elbow area.The patient was told to contact zimvie.The patient was not sent a replacement product.The product is not expected to be return.No additional patient consequences/ further information has been reported.The spf xl iib was not returned for further evaluation.
Additional Manufacturer 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 for trend.

• Brand Name: SPF-XL IIB 2/DM
• Common Device Name: SPF
• 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: 16991739
• Report Number: 0002242816-2023-00054
• Device Sequence Number: 6815029
• Product Code: LOE
• UDI-Device Identifier: 00812301020089
• UDI-Public: 00812301020089
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P850035/S023
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic