MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	15355500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.No product malfunction was reported.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury; nerve damage due to surgical trauma." ".Compatibility: do not use reline system with components of other systems than armada system.Refer to the armada system instructions for use for a list of the armada system indications of use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." no product replaced.
Event or Problem Description
On (b)(6) 2017, a patient underwent an extreme lateral interbody fusion procedure at l2-l5 levels and a posterior fusion procedure at t9-s2ai levels.During in-situ rod bending, the anterior longitudinal ligament was ruptured at l2/3 level.Reportedly, on (b)(6) 2017, patient underwent a revision procedure to place a mesh cage and arrow graft in an effort to prevent the xlif cage from backing out.No patient injury was reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7025702
• Report Number: 2031966-2017-00167
• Device Sequence Number: 1145381
• Product Code: NKB
• UDI-Device Identifier: 00887517510143
• UDI-Public: 00887517510143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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 Model Number: 15355500
• Device Lot Number: CT62636
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/13/2017
• 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: 78 YR