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

Model Number CIE3-11-28-00

Device Problem Migration (4003)

Patient Problem Aspiration/Inhalation (1725)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient aspirated in recovery immediately post op in (b)(6) 2018 and was transferred to icu.She was there a while where she coughed excessively with spasms.The operating surgeon believes this may have caused the varilift-lx device to dislodge or migrate leading to the need for the revision surgery.Surgery occurred to reposition the device and add supplemental fixation.The device remains in the patient.There is no evidence of device failure or malfunction.

Event Description

Varilift-lx revision surgery 6 months post-op.

• 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: 8089098
• MDR Text Key: 127877948
• Report Number: 3008009850-2018-00008
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00813210020139
• UDI-Public: 00813210020139
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2020
• Device Model Number: CIE3-11-28-00
• Device Lot Number: BB008C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2015
• 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: 69 YR