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

Model Number	CIE3-12-24-00
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is currently no evidence of device malfunction or failure.
Event or Problem Description
Report of patient reporting back/leg pain 2 days post varilift-l surgery.Surgeon reports that the device was placed too far lateral in the index surgery requiring removal of the device.
Additional Manufacturer Narrative
Investigation of this report concluded that use error caused or contributed to this event.The device was placed too far lateral during the index surgery contributing to the need for the revsion surgery.There was no device failure or malfunction.

• Brand Name: VARILIFT-LX
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 1130 rutherford lane; suite 200; austin 78753
• MDR Report Key: 6974296
• Report Number: 3008009850-2017-00006
• Device Sequence Number: 16450998
• Product Code: MAX
• UDI-Device Identifier: 00813210020092
• UDI-Public: 00813210020092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: CIE3-12-24-00
• Device Lot Number: 08151003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR