MAUDE Adverse Event Report: EBI, LLC. EBI SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATOR; STIMULATOR, INVASIVE BONE GROWTH

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a revision was performed of a device that was included in recall zfa 2018-00048.Attempts have been made and no further information has been provided.

Event Description

It was reported the patient underwent a revision surgery to explant an spf-xl iib 2/dm device.Attempts have been made and no further information has been provided.No additional patient consequences have been 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 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: h3: device evaluated by manufacturer updated to no.H6: patient code updated to 3190: no information.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.H3 other text : the device has not been returned.

• Brand Name: EBI SPF-XL IIB 2/DM IMPLANTABLE SPINAL FUSION STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7646176
• MDR Text Key: 112601984
• Report Number: 0002242816-2018-00022
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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: Physician
• Device Expiration Date: 04/20/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: N/A
• Other Device ID Number: (01) 0 0812301 02008 9
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0287-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention