MAUDE Adverse Event Report: EBI, LLC. EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR; STIMULATOR, INVASIVE BONE GROWTH, SPF-XL IIB 2/DM

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Because the part and lot numbers are unknown, the device history records could not be pulled and reviewed.Without a product return, no product evaluation is able to be conducted.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

The distributor reported the surgeon explanted the device because the patient said he was experiencing pain at the location of the battery.More information was requested and has yet to be received.

Manufacturer Narrative

(b)(4).Review of device history records show the lot released with no recorded anomaly or deviation.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

Additional information was received from the sales representative.The product was implanted on (b)(6) 2016 and explanted on (b)(6) 2017.It is reported that there was no injury after implantation.

• Brand Name: EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH, SPF-XL IIB 2/DM
• 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: 6442373
• MDR Text Key: 71164281
• Report Number: 0002242816-2017-00010
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

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 Expiration Date: 04/18/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: UNKNOWN
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention