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

Model Number	11455040
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was returned for evaluation.Review of the returned rods found a complete lack of final lock screw torque down contact markings, which indicates the 90-in lbs of required torque was not applied.No additional investigation required.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal.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: 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 presenting a risk of serious injury to the patient.These devices can break when subjected to the increased load associated with delayed union or nonunion.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Care should be taken to insure that all components are ideally fixated prior to closure." "post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation, and migration, as well as to other complications.".
Event or Problem Description
On (b)(6) 2020, a patient underwent a spinal surgery at l4/5.Same day post-operative x-rays showed no evidence of any malfunctions.Three weeks post-op x-rays revealed a left side rod migration.On (b)(6) 2020, a revision surgery was performed where both rods, and tulips were replaced.

• 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: 10853271
• Report Number: 2031966-2020-00206
• Device Sequence Number: 4169057
• Product Code: NKB
• UDI-Device Identifier: 00887517591029
• UDI-Public: 887517591029
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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: 11455040
• Device Lot Number: CT121831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 13550000