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

Model Number	13117545
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a patient underwent a extreme lateral interbody fusion procedure from l3 to l5 fixed with posterior fixation.On a unknown date it was discovered that the right screw at l5 was deviated inward.This deviation was confirmed to be the result of proper trajectory not being achieved in the index procedure.On (b)(6) 2021 a revision occurred where the deviated screw was re used and put in the proper position.The was no report of any adverse consequences to the patient as a result of the malplaced screw and the patient is considered to be recovering.
Additional Manufacturer Narrative
The lot number was reported to be either n288197 or n295595.No product was returned as no product fault was alleged and the involved device remains in-situ.No radiographs could be provide showing the initial or revised construct confirming the complaint.No additional information could be obtained.The root cause is considered to be an inadvertent use error and the result of screw malplacement during the index procedure.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." "warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 12523456
• Report Number: 2031966-2021-00129
• Device Sequence Number: 4031396
• Product Code: NKB
• UDI-Device Identifier: 00887517582782
• UDI-Public: 887517582782
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: Health Professional
• Device Model Number: 13117545
• Device Lot Number: SEE H10
• 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: 09/13/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR