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 Codes	Fall (1848); Inadequate Pain Relief (2388)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient is a (b)(6) female had l2-l3 standalone varilift placed (b)(6) 2016 for adjacent segment disease above l3-s1 fusion with pedicle screws.She came to clinic in wheelchair approximately 6 weeks postoperative ((b)(6) 2017).The patient was confused and disoriented.She was accompanied by family member who indicated she had multiple falls and was not able to walk.Patient was also being treated with antibiotics for a uti.All spinal implants, including pedicle screws from a previous fusion were observed to have migrated upon radiographic image review.Investigation is ongoing.Not returned to manufacturer.
Event or Problem Description
Report of varilift lx device migration 6 weeks post-op.

• 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: 6290259
• Report Number: 3008009850-2017-00002
• Device Sequence Number: 13612554
• Product Code: MAX
• UDI-Device Identifier: 00813210020122
• UDI-Public: 00813210020122
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 01/31/2017
• 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: 62 YR