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

Model Number	CIE3-13-24-00
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information available to date suggests that the removal occurred due to new leg pain reported by the patient 1 year 2 months post-op.The patient had a knee replacement surgery and was attending physical therapy when the leg pain began.No images or additional information was provided by the operating surgeon; thus, the root cause cannot be established with certainty.There is no information that suggests a device malfunction or device failure caused the event to occur.
Event or Problem Description
A varilift-lx removal was reported for one implant in a bilateral plif 1 year and 4 months post-op.

• Brand Name: VARILIFT-LX
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 1130 rutherford lane; suite 200; austin TX 78753
• MDR Report Key: 8075309
• Report Number: 3008009850-2018-00007
• Device Sequence Number: 2363870
• Product Code: MAX
• UDI-Device Identifier: 00813210020085
• UDI-Public: 00813210020085
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 11/01/2021
• Device Model Number: CIE3-13-24-00
• Device Lot Number: AF008B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR