MAUDE Adverse Event Report: WENZEL SPINE, INC. VARILIFT-LX; LUMBAR INTERBODY FUSION DEVICE

Model Number CIE3-12-24-00

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Our investigation of this event with the information to date suggests that the event (migration and revision) was due to off-label use of the varilift-lx device in a patient with grade 2 or 3 spondylolisthesis.The indications for use and all labeling for the varilift-lx informs users that this device is for use in patients with up to a grade 1 spondylolisthesis.There is no indication of device failure or malfunction.The varilift-lx device was not removed from the patient.

Event Description

It was reported that a removal of a varilift-lx device was attempted due a reported migration in a patient with grade 2+ spondylolisthesis.

• Brand Name: VARILIFT-LX
• Type of Device: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 1130 rutherford lane; suite 200; austin TX 78753
• Manufacturer (Section G): WENZEL SPINE, INC.; 1130 rutherford lane; suite 200; austin TX 78753
• Manufacturer Contact: beckinam nowatzke ; 1130 rutherford lane; suite 200; austin, TX 78753
• MDR Report Key: 7487239
• MDR Text Key: 107374331
• Report Number: 3008009850-2018-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00813210020092
• UDI-Public: 00813210020092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2021
• Device Model Number: CIE3-12-24-00
• Device Lot Number: AF024A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2016
• 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): Required Intervention
• Patient Age: 61 YR