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

Model Number	16460500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs provided confirm the alleged malfunction.It is unknown if fusion had been completed.It is unknown if the patient followed post-operation restrictions or suffered a fall.The post-operative left rod fracture was not returned for evaluation.The fractured distal portion of the rt rod and associated fractured screw were returned and evaluated.Examination confirmed fracture initiated from notching incurred during initial usage where tulip was locked down and suggest the root cause is a result of reuse fatigue damage and or excessive force.The root cause of the post-operative screw and rod fracture was unable to be determine though radiographs and screw fracture evaluation point to extreme force which suggest excessive loading due to anatomical challenges or excessive force from a possible unreported fall.No additional investigation can be completed at this time.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Warnings, cautions and precautions: these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ".Patient education: the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration well as to other complications." ".Single use: reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents.Resterilization may result in damage or decreased performance.".
Event or Problem Description
On (b)(6) 2019 a patient underwent a posterior fixation procedure without a reported issue.On (b)(6) 2020 a revision surgery was performed due to a broken rod and during the procedure a rod broke and screw fractured at s1 and were replaced.No patient injury reported.

• 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: 10922884
• Report Number: 2031966-2020-00212
• Device Sequence Number: 1283057
• Product Code: NKB
• UDI-Device Identifier: 00887517594426
• UDI-Public: 887517594426
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 16460500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR