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

Model Number CIE2-15-24-00

Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

Per the surgeon in the case, there was no device malfunction.Patient had very soft bone and should not have been implanted with the varilift-l device as a stand-alone.Supplemental fixation was added and the patient is doing fine post-revision surgery.The results of the investigation also note that the surgeon used 2 different size varilift-l implant devices at each level which is in contradiction to clearly stated requirements in the varilift-l surgical technique "bilateral devices implanted in the disc space must be of equal size.".

Event Description

Revision surgery to add supplemental fixation for patient 3 weeks post varilift-l 2-level bilateral plif surgery due to wound hematoma and vertebral fracture.No device malfunction reported.

• Brand Name: VARILIFT-L
• Type of Device: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 203; austin TX 78746
• Manufacturer (Section G): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 203; austin TX 78746
• Manufacturer Contact: beckinam nowatzke ; 206 wild basin road; building a, suite 203; austin, TX 78746 ; 5123148271
• MDR Report Key: 5743121
• MDR Text Key: 47980504
• Report Number: 3008009850-2016-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00813210020023
• UDI-Public: 00813210020023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131296
• 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: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: CIE2-15-24-00
• Device Lot Number: 08150110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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: 70 YR