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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Itching Sensation (1943); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device currently remains implanted, therefore 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 patient called seeking information about the recall (zfa 2017-245).She reported she is experiencing itching that feels like it is coming from inside and redness at the surgical site, as well as headaches.She said her physician recommended leaving the stimulator in until her next appointment on (b)(6) 2017 because he felt like it was working well.

• Brand Name: SPF-PLUS 60/M
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• 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: 6826454
• MDR Text Key: 83844351
• Report Number: 0002242816-2017-00041
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: N/A
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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): Other