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

Model Number	CIE2-11-24-00
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The removal surgery took place on (b)(6) 2017, we (the manufacturer) were made aware that the removal surgery was scheduled on (b)(6) 2017.During the course of our investigation, we were made aware of additional information regarding the circumstances of the removal that reasonably suggested our device may have either caused or contributed to the need for the device removal on (b)(6) 2017 and the mdr assessment as a reportable event was made on (b)(6) 2017.The root cause for this product event is yet unknown and the investigation is ongoing.Follow-up mdr(s) will be submitted as the investigation is concluded.Device held at hospital.
Event or Problem Description
Reported varilift-l removal surgery 8 months post-op due to patient complaint of persistent radicular leg pain on the left-side.
Additional Manufacturer Narrative
Based on the information received to date, the root cause of the event is most likely due to improper placement of the device during the index surgery.No evidence of device malfunction or failure was found.

• Brand Name: VARILIFT-L
• Common Device Name: LUMBAR INTERBODY FUSION DEVICE
• Manufacturer (Section D): WENZEL SPINE, INC.; 1130 rutherford lane; suite 200; austin 78753
• MDR Report Key: 6581420
• Report Number: 3008009850-2017-00003
• Device Sequence Number: 13711225
• Product Code: MAX
• UDI-Device Identifier: 00813210020009
• UDI-Public: 00813210020009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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: 12/08/2020
• Device Model Number: CIE2-11-24-00
• Device Lot Number: 08150801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 07/18/2017
• 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: 55 YR