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

Model Number	16171111
Medical Device Problem Codes	Detachment Of Device Component (1104); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was received and evaluation was performed.During visual inspection damage was observed.Observed damage was duplicated by application of excessive force.Examination of the provided ct scan and radiographs suggest the disassembly and breach may be related to over angulation as a result of anatomical challenges noted.A review of the device history record noted no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: ".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.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".Use nvm5 stimulation probe to test screws once inserted into bone (fig.10)." ".Care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." ".Potential risks identified with the use of this system, which may require additional surgery, include: · bending, fracture or loosening of implant component(s).".
Event or Problem Description
On (b)(6) 2018 patient underwent an interbody replacement procedure with posterior fixation at l2-l5 levels with no reported issues.Post-operative patient experienced pain and underwent a revision procedure on (b)(6) 2018.During the procedure a loose tulip was found at l2 level and pedicle breach at the l1-l2 disc space.L2 screw and lock screw were replaced.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: TTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7649127
• Report Number: 2031966-2018-00111
• Device Sequence Number: 19245552
• Product Code: NKB
• UDI-Device Identifier: 00887517587497
• UDI-Public: 00887517587497
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: Physician
• Device Model Number: 16171111
• Device Lot Number: JP15477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1