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

Model Number	CIE2-15-24-00
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884)
Date of Event	05/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the surgeon in the case, there was no device malfunction.Patient had very soft bone and should not have been implanted with the varilift-l device as a stand-alone.Supplemental fixation was added and the patient is doing fine post-revision surgery.The results of the investigation also note that the surgeon used 2 different size varilift-l implant devices at each level which is in contradiction to clearly stated requirements in the varilift-l surgical technique "bilateral devices implanted in the disc space must be of equal size.".
Event or Problem Description
Revision surgery to add supplemental fixation for patient 3 weeks post varilift-l 2-level bilateral plif surgery due to wound hematoma and vertebral fracture.No device malfunction reported.

• Brand Name: VARILIFT-L
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 203; austin TX 78746
• MDR Report Key: 5743121
• Report Number: 3008009850-2016-00003
• Device Sequence Number: 842766
• Product Code: MAX
• UDI-Device Identifier: 00813210020023
• UDI-Public: 00813210020023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

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: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: CIE2-15-24-00
• Device Lot Number: 08150110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2016
• Initial Report FDA Received Date: 06/22/2016
• 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: 70 YR