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

Model Number N/A

Device Problems Nonstandard Device (1420); Unexpected Therapeutic Results (1631); Device-Device Incompatibility (2919)

Patient Problem Pain (1994)

Event Type  Injury  

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 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)
• Type of Device: SPF PLUS MINI
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: shaan polius ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 8631438
• MDR Text Key: 145757042
• Report Number: 0002242816-2019-00015
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850035/S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0287-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention