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

Model Number CIE2-11-24-00

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

Based on the results of the investigation no evidence of device malfunction or manufacturing defect was found or reported.The root cause for the removal is due to surgical technique error by the user.The implant was not placed at the correct angle during placement in the disc space.Device not returned to manufacturer.

Event Description

It was reported that a varilift-l implant migrated intra-operatively due to improper surgical technique by the user requiring surgical intervention to retrieve the device.

• Brand Name: VARILIFT-L
• Type of Device: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 206 wild basin road; building a, suite 200; austin TX 78746
• Manufacturer (Section G): WENZEL SPINE, INC.; 206 wild basin rd.; building a, suite 203; austin TX 78746
• Manufacturer Contact: beckinam nowatzke ; 206 wild basin rd; building a, suite 203; austin, TX 78746 ; 5123148271
• MDR Report Key: 5487709
• MDR Text Key: 39927221
• Report Number: 3008009850-2016-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2016

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
• Device Operator: Physician
• Device Expiration Date: 09/04/2020
• Device Model Number: CIE2-11-24-00
• Device Lot Number: 08150504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2015
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2015
• 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: 44 YR