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

Model Number	13114540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation as it was left in situ.No allegation of product malfunction has been reported nor were radiographs or images provided to confirm the reported event.Patients bone quality is unknown.A vertebral fracture may be the result of implant selection, implant placement or poor bone quality.Even though root cause cannot be confirmed based on the information provided patient related issues may be related to the alleged event.No further investigation can be completed at this time.Labeling review: "potential risks identified with the use of this system, which may require additional surgery, include:bending, fracture or loosening of implant component, loss of fixation nonunion or delayed union, fracture of the vertebra." "correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." contraindications: "contraindications include, but are not limited to: patients with inadequate bone stock or quality." left in situ.
Event or Problem Description
On (b)(6) 2019, a patient underwent vertebral replacement at l2 using x-core and posterior spinal fusion at l1-l3 using reline.As per reporter, a fracture at l1 level was identified three weeks post operatively.On (b)(6) 2019 a revision procedure was performed, and the fixation was extended to t11-l4.

• 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: 9099732
• Report Number: 2031966-2019-00238
• Device Sequence Number: 19499378
• Product Code: NKB
• UDI-Device Identifier: 00887517581938
• UDI-Public: 887517581938
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: Health Professional
• Device Model Number: 13114540
• 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: 08/26/2019
• Initial Report FDA Received Date: 09/20/2019
• Patient Sequence Number: 1
• Patient Age: 83 YR