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

Model Number	CIE3-10-28-00
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still in progress for this product event.Information to date suggests there was no malfunction or failure of the varilift-lx device.Device not returned to manufacturer.
Event or Problem Description
A removal of a varilift-lx device was reported due to possible migration 6 months post index surgery.
Additional Manufacturer Narrative
New information provided by the surgeon stated that the reason for the removal surgery was due to a retropulsion of the varilift device cause by over-aggressive physical therapy too soon after surgery.Based on this new information, the root cause of the event is due to patient noncompliance.The varilift-lx ifu discuss post-operative mobilization and advises the surgeon to advise the patient to be careful not to place significant loads on the spine for the first 3 months after surgery.It was reported that the patient was in physical therapy too soon post-index surgery, was placed over a exercise ball and the spine was overflexed causing the device to retropulse (migrate).The patient was doing fine with the device until this occurred, thus, there is no evidence of a device malfunction or design issue that caused or contributed to this event.

• 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: 6247882
• Report Number: 3008009850-2017-00001
• Device Sequence Number: 323481
• Product Code: MAX
• UDI-Device Identifier: 00813210020122
• UDI-Public: 00813210020122
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2017

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: 02/12/2021
• Device Model Number: CIE3-10-28-00
• Device Lot Number: 08150902
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/03/2017
• 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: 47 YR