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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date: device was implanted in (b)(6) 2015.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.Not returned to manufacturer.

Event Description

It was reported that the patient has issues with that spf unit.She states that she feels like something is wrong, and that she is experiencing pain in the area where the unit is implanted.She states that her pain level is 5-7 on a scale of 1-10.She states that no part of the unit has been explanted and she can feel the unit.The patient spoke to her surgeon who stated that she "shouldn't be able to feel it".She stated that she has tried to have an mri scan, but has been turned down by 3 facilities due to mri safety information found online.The patient refused the offer of the spf physician manual which includes mri safety information, and is currently searching for a new doctor.The unit still remains implanted in the patient at this time.No known adverse event was reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The device was not returned to zimmer biomet for evaluation as it is still implanted.The reported event was unable to be confirmed due to limited information from the customer.The device history record (dhr) was reviewed and no discrepancies were found.The root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: h6: device code updated to 3190: insufficient information.H6: method code updated to 3331: analysis of production records.H6: method code updated to 4114: device not returned.H6: results code updated to 3221: no findings available.H6: conclusion code updated to 4315: cause not established.The following sections were corrected: h4: device manufacturer date corrected.H3 other text : the device has not been.Returned.

Event Description

It was reported that the patient has issues with the implanted spf unit.She states that she feels like something is wrong, and that she is experiencing pain in the area where the unit is implanted.She states that her pain level is 5-7 on a scale of 1-10, with 10 being the worst.She states that no part of the unit has been explanted and she can feel the unit.The patient spoke to her surgeon who stated that she "shouldn't be able to feel it".She stated that she has tried to have an mri scan, but has been turned down by 3 facilities due to mri safety information found online.The patient stated that she did visit a new doctor to try to get it explanted but doctors will not do the procedure as they do not want to be held liable.The unit still remains implanted in the patient at this time.No additional patient consequences were reported.

• Brand Name: SPF-PLUS 60/M
• Type of Device: SPF IMPLANTABLE SPINAL FUSION STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8568340
• MDR Text Key: 143671147
• Report Number: 0002242816-2019-00011
• Device Sequence Number: 1
• Product Code: LOE
• UDI-Device Identifier: 00812301020126
• UDI-Public: 00812301020126
• Combination Product (y/n): N
• PMA/PMN Number: 850035/S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2017
• 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
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0287-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other