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

Model Number N/A

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device history records show the lot released with no recorded anomaly or deviation.The device was discarded, therefore no device evaluation can be performed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It is reported the spf device failed before closing the patient during a lumbar fusion revision of non-zimmer biomet devices.The spf device was removed and nothing was implanted in its place.There was no delay in surgery.

• Brand Name: EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH, SPF-PLUS 60/M
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 6882275
• MDR Text Key: 86983969
• Report Number: 0002242816-2017-00043
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: 409718
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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