MAUDE Adverse Event Report: EBI, LLC. SPF PLUS-MINI (60 ¿A/W); SPF PLUS MINI

Model Number	N/A
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: the event occurred sometime in (b)(6) 2019.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient had the spf implanted approximately 3 years after being implanted.The patient indicated that the device was explanted because it was not mri safe.She stated that spf did not cause her to feel well, and she experienced pain.The patient stated that she has had no quality of life for the past 3 years, and that the spf affected her immune system.The patient also indicated that she had a bone graft that never healed due to the spf.No additional patient consequences were reported.

• Brand Name: SPF PLUS-MINI (60 ¿A/W)
• Common Device Name: SPF PLUS MINI
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8631438
• Report Number: 0002242816-2019-00015
• Device Sequence Number: 1942212
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P850035/S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 10-1398M
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0287-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention