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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Cyst(s) (1800)

Event Type  Injury  

Event Description

It was reported that patient developed cyst and abscess formation in the area of spf implant post-op.Patient outcome: no information has been provided at this time.

Manufacturer Narrative

No product was returned to manufacturer.Current information is insufficient to permit a conclusion as to the cause of the event.Date of event - unknown.Expiration date - unknown.Implant date - (b)(6) 2013 (exact date unknown).Explant date - unknown.Device manufacture date ¿ unknown.

• Brand Name: SPF SPINAL FUSION STIMULATOR
• Type of Device: SPF-PLUS 60/M
• 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: 3582204
• MDR Text Key: 4061208
• Report Number: 0002242816-2014-00003
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2013
• 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