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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: unknown.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 had the stimulator spinal fusion removed due to pain.The patient is a (b)(6) male with history of prior posterior cervical thoracic fusion with an implanted bone growth stimulator who now presents for elective explantation of the bone stimulator generator as per manufacturer recommendation update: the reason for the removal was due to intermittent pain the patient has been experiencing in the area of the bone stimulator and requested an elective explantation of the bone stimulator generator as per manufacturer recommendation.

• Brand Name: SPF-XL IIB 2/DM
• Type of Device: IMPLANTABLE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: tanisha tucker ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 11967570
• MDR Text Key: 255190782
• Report Number: 0002242816-2021-00089
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020089
• UDI-Public: 00812301020089
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: 225250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/09/2021
• 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
• Patient Outcome(s): Required Intervention