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

Model Number	13015540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received as the fractured portion of the device currently remains in situ and the remainder was not returned.Radiograph's were provided but could not confirm the fracture prior to attempted removal.Photographs provided of the fractured screw suggest a high reverse flexural load fracture.The root cause of the screw fracture is unknown but review of the information provided suggests excessive off angled force during removal as a probable cause.No additional investigation required.Labeling review ".Potential adverse events and complications - with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative nd postoperative complications that may result in the need for additional surgeries.Potential risks identified with the use of this system, which may require additional surgery, include: ending, fracture or loosening of implant component(s)¿" ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials." ".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.".
Event or Problem Description
On (b)(6) 2022 a patient underwent a revision procedure to extend a pre existing construct at l3-l5 to t9-pelvis due to a continued decline in patient pathology.During the hardware removal portion of the revision surgery it was discovered that the right screw at l5 had fractured.As a consequence the fractured portion was left in patient.The remainder of the revision occurred without issue and the patient is currently recovering well.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; san diego, CA 92121
• MDR Report Key: 13444144
• Report Number: 2031966-2022-00026
• Device Sequence Number: 4492559
• Product Code: NKB
• UDI-Device Identifier: 00887517536846
• UDI-Public: 887517536846
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

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: 13015540
• Device Lot Number: JP5257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose