MAUDE Adverse Event Report: EBI, LLC. SPF SPINAL FUSION STIMULATOR

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

Patient reports having an spf unit implanted on an unknown date.Subsequently, patient had an mri procedure on an unknown date and reports pain and discomfort in area where the spf unit was implanted.Patient reports that spf unit was explanted on an unknown date.Patient further reports pain and discomfort in the implant area after the revision.

Manufacturer Narrative

No product was returned to manufacturer.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).Mri statement is included with patient card and states the following: for mri centers: the biomet spf spinal fusion stimulator has received fda approval for the claim of mri safe for the spf-2t and spf-xl iib models when used in mr environments up to 1.5 tesla.To access complete full prescribing and mri information, (b)(4).

• Brand Name: SPF SPINAL FUSION STIMULATOR
• Type of Device: STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: david talish ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 3629042
• MDR Text Key: 4184789
• Report Number: 0002242816-2014-00014
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/16/2014

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: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention