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

Model Number CIE2-11-24-00

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

Based on the results of the investigation no evidence of device malfunction or manufacturing defect was found.The root cause for the removal is due to patient selection and worsening of the patient's spondylolisthesis.Device not returned to manufacturer.

Event Description

A removal of varilift-l implant was performed due to patient spine instability.The device was removed in one piece and in good shape.Patient is reported to be doing well post-op.

• Brand Name: VARILIFT-L
• Type of Device: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 200; austin TX 78746
• Manufacturer (Section G): WENZEL SPINE, INC.; 206 wild basin rd.; building a, suite 203; austin TX 78746
• Manufacturer Contact: beckinam nowatzke ; 206 wild basin rd; building a, suite 203; austin, TX 78746 ; 5123148271
• MDR Report Key: 5353437
• MDR Text Key: 35346292
• Report Number: 3008009850-2015-00002
• Device Sequence Number: 1
• Product Code: MAX
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2016

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 Expiration Date: 06/10/2020
• Device Model Number: CIE2-11-24-00
• Device Lot Number: 08150109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2015
• 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): Hospitalization
• Patient Age: 35 YR