MAUDE Adverse Event Report: NUVASIVE, INC. MAS PLIF FIXATION SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	7094540
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirmed the event.The device has not returned for evaluation.Revising surgeon indicated screw placement during the index surgery contributed to the event.The patient's activity level and adherence to post-operative care instructions are also unknown.No root cause has been identified.Labeling review notes the following: warnings cautions and precautions: "potential risks identified with the use of this device system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss fixation.".
Event or Problem Description
A patient underwent fusion with interbody cage and pedicle screw fixation at l4-l5.Surgeon reported the inferior screw at l5 pulled out allowing the cage to migrate.Revision surgery was completed to replace the screws.

• Brand Name: MAS PLIF FIXATION SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5536835
• Report Number: 2031966-2016-00023
• Device Sequence Number: 726417
• Product Code: MNI
• UDI-Device Identifier: 00887517173966
• UDI-Public: 00887517173966
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 7094540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2016
• Initial Report FDA Received Date: 03/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1