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

Model Number	16018580
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a patient underwent a transforaminal lumbar interbody fusion procedure from t10 to s2.The surgery was completed without issue.On (b)(6) 2023 it was discovered via radiograph during a routine follow up that the shaft of the left s2ai screw fractured where the head meats the tulip.The patient is reported to be asymptomatic and no further action will be taken at this time.The patient will continue to be monitored.
Additional Manufacturer Narrative
No device was returned as the screw remains in situ and the patient is currently asymptomatic, a ct scan provided confirmed the alleged complaint.The patients pot op activity levels or whether they experienced a fall or other accident could not be confirmed.The poor quality of the provided radiographs were unable to confirm construct configuration, loading or if fusion had occurred.Due to a lack of information provide no root cause could be determined, although construct loading, excessive post operative activity, extended period of non fusion, and or patient related factors (parkin's disease) as potential causes or contributors.A review of the manufacturing history found no material nonconformance, no manufacturing error, nor discrepancies with respect to material type, treatments or dimension that may have caused or contributed to this event.Parts met acceptance criteria upon release.No additional investigation can be completed at this time.Label review: ".Contraindications: contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".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." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".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." ".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." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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 even though restrictions in activity are followed." ".Post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16963678
• Report Number: 2031966-2023-00112
• Device Sequence Number: 14763307
• Product Code: NKB
• UDI-Device Identifier: 00887517554376
• UDI-Public: 887517554376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/19/2023

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: 16018580
• Device Lot Number: N304382
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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 Age: 66 YR
• Patient Sex: Female