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

Model Number	CIE3-11-24-00
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information known to date, the use of bmp during the index surgery caused an osteolytic response in the patient at the levels where the varilift-lx devices were implanted.The osteolytic response led to a migration of the devices and an additional surgery for removal of the devices 2.5 months post-op.There is no information to date to suggest that the a defect or malfunction of the varilift-lx caused or contributed to this event.The use of bmp with the varilift-lx devices is considered off-label use.
Event or Problem Description
Varilift-lx removal 2.5 months post-op due to device migration caused by osteolytic response from bmp use at index surgery.

• 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: 7899517
• Report Number: 3008009850-2018-00005
• Device Sequence Number: 1914203
• Product Code: MAX
• UDI-Device Identifier: 00813210020078
• UDI-Public: 00813210020078
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: 10/20/2022
• Device Model Number: CIE3-11-24-00
• Device Lot Number: BC024D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/21/2018
• 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: 61 YR