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

Model Number	CIE3-11-28-00
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the history of the device, a potential contributing factor to the device movement is the endplate was under prepared evidenced by osteophytes or bone spurs on the posterior end of the vertebral bodies of the patient (based on reporting) coupled with device used was potentially undersized evidenced by the surgeon removing the device in an expanded state, these factors have contributed to device migration in the past; however without images, it is difficult to confirm the device moved post-op (versus not placed correctly at index) or to determine the exact cause of any movement that might have occurred.However, a device malfunction or failure is not likely to have occurred based on the device history review and the information known from the removal surgery (device removed intact, expanded, and full of bone).
Event or Problem Description
Varilift-lx removal surgery 1 month 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: 7990869
• Report Number: 3008009850-2018-00006
• Device Sequence Number: 1681960
• Product Code: MAX
• UDI-Device Identifier: 00813210020139
• UDI-Public: 00813210020139
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 02/09/2023
• Device Model Number: CIE3-11-28-00
• Device Lot Number: BJ008E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/22/2018
• 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: 59 YR