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

Model Number CIE3-10-28-00

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494); Malposition of Device (2616)

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

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

Investigation is still in progress for this event.

Event Description

Report of removal surgery scheduled for varilift lumbar device approximately 6 weeks post-op.Investigation is in progress.

• Brand Name: VARILIFT-LX
• Type of Device: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 203; austin TX 78746
• Manufacturer (Section G): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 203; austin TX 78746
• Manufacturer Contact: beckinam nowatzke ; 206 wild basin road; building a, suite 203; austin, TX 78746 ; 5123148271
• MDR Report Key: 5659378
• MDR Text Key: 45298508
• Report Number: 3008009850-2016-00002
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00813210020122
• UDI-Public: 813210020122
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/12/2020
• Device Model Number: CIE3-10-28-00
• Device Lot Number: 08150902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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: 65 YR