MAUDE Adverse Event Report: EBI, LLC. SPF-PLUS 60/M; SPINE FUSION STIMULATOR (SPF)

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: the date of the adverse event was not reported by the patient.The device will not be returned for analysis as it is still implanted in the patient.A supplemental medwatch 3500a will be submitted when additional information is received.Device not returned to manufacturer.

Event Description

It was reported that the patient stated that she was experiencing pain and bone non-union/ mal-union from the spine implantable stimulator.Patient stated that she needs a new surgery but has not been able to communicate with her previous surgeon.She provided no further information and stated that she will contact her attorney.

Event Description

It was reported that the patient had the spf explanted approximately four years after it was implanted.The patient indicated that the device was explanted because it was not mri safe.She stated that spf caused her to feel unwell and she experienced pain.The patient stated that she has had no quality of life and that the spf affected her immune system.The patient stated that she had a bone graft that never healed due to the spf.No additional patient consequences were reported.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.The device was not returned to zimmer biomet for evaluation.The reported event was unable to be confirmed due to limited information received 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: conclusions code updated to 4315: cause not established.Multiple initial mdr reports were filed for this event, please see associated reports: 0002242816-2019-00006, and 0002242816-2019-00015.H3 other text : the device has not been returned.

• Brand Name: SPF-PLUS 60/M
• Type of Device: SPINE FUSION STIMULATOR (SPF)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 8386952
• MDR Text Key: 137742313
• Report Number: 0002242816-2019-00006
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• PMA/PMN Number: P850035/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: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2017
• 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: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0287-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention