MAUDE Adverse Event Report: SPINEOLOGY, INC ELITE EXPANDABLE INTERBODY FUSION DEVICE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 541-0019

Device Problem Collapse (1099)

Patient Problem Pain (1994)

Event Date 03/14/2022

Event Type  Injury  

Event Description

The patient underwent an interbody fusion with placement of an elite expandable device on (b)(6) 2020 without incident.In (b)(6) 2021, the patient experienced failed posterior construct resulting in a revision surgery to replace broken 3rd party screws.Approximately six (6) months following the revision surgery, the patient reportedly experienced return of lower back pain prompting additional medical attention.Imaging showed fracture to the implant bolt.A revision surgery was conducted on (b)(6) 2022 via alif procedure to remove and replace the implant.The patient is no longer experiencing any clinical issues or complications.

• Brand Name: ELITE EXPANDABLE INTERBODY FUSION DEVICE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): SPINEOLOGY, INC; 7800 3rd street north; suite 600; saint paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY, INC; 7800 3rd street north; suite 600; saint paul MN 55128 5455
• Manufacturer Contact: megan polos ; 7800 3rd street n.; suite 600; saint paul, MN 55128-5455 ; 6512568500
• MDR Report Key: 14085525
• MDR Text Key: 289093764
• Report Number: 2135156-2022-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: M74054100190
• UDI-Public: +M74054100190/$$3240601S90730H
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 541-0019
• Device Lot Number: S90730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 3RD PARTY POSTERIOR CONSTRUCT.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female