MAUDE Adverse Event Report: SPINEOLOGY INC. ELITE EXPANDABLE INTERBODY FUSION DEVICE; SPINAL IMPLANT

Catalog Number 540-0303

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

In (b)(6) 2016, the patient underwent a lumbar spinal fusion surgical procedure at an unspecified level(s) with implantation of an elite expandable device, optimesh devices, and threshold spinal construct.On or about (b)(6) 2017, the patient returned to the physician's office for unspecified reasons.An evaluation was performed which reportedly revealed that the elite expandable device had migrated posteriorly.The evaluation further noted that the elite expandable device remained in the expanded state within the disc space and had not collapsed.The patient was returned to surgery on (b)(6) 2017 at which time the physician reported that all of the pedicle screws were loose.All instrumentation was removed.The physician experienced difficulty in gaining access to the elite expandable device in the intervertebral disc space due to the presence of scar tissue as well as difficulty in removing the device due to its expanded state.Following removal of the elite expandable device and spinal construct, another manufacturer's expandable interbody device and spinal construct was placed.The information contained in this report is being provided to fda to comply with medical device reporting regulations and is based on information submitted by others that may not be factually correct.

• Brand Name: ELITE EXPANDABLE INTERBODY FUSION DEVICE
• Type of Device: SPINAL IMPLANT
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; st. paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; st. paul MN 55128 5455
• Manufacturer Contact: jacqueline hauge ; 7800 3rd street n.; suite 600; st. paul, MN 55128-5455
• MDR Report Key: 6690005
• MDR Text Key: 79287685
• Report Number: 2135156-2017-00008
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2017

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 Catalogue Number: 540-0303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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
• Patient Outcome(s): Other