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

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Type  Injury  

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 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.

• Brand Name: SPF-XL IIB 2/DM
• Type of Device: SPF
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 16991739
• MDR Text Key: 315846216
• Report Number: 0002242816-2023-00054
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020089
• UDI-Public: 00812301020089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850035/S023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female