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

Model Number CIE3-13-24-00

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

Our investigation of this event with the information to date suggests that the event is due to potential inherent instability in the patient's spine that caused a slip at l4 and pressed (or caused the device to press) on the patient's nerve causing pain four months post-op.There is no evidence of device malfunction or direct device cause/contribution to the need for revision surgery.

Event Description

It was reported that a revision of a varilift-lx device was preformed due to intractable back pain in a patient 4 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: 7791117
• MDR Text Key: 117419457
• Report Number: 3008009850-2018-00004
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00813210020092
• UDI-Public: 00813210020092
• 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: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: CIE3-13-24-00
• Device Lot Number: BC024C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• 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: 62 YR