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

Model Number	15460500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a t4 to s2ai posterior fixation procedure on an unknown date.Subsequently, the patient experienced post-operative pain and an x-ray revealed one of the rods had fractured at l3/4.A revision surgery was performed; however, it was reported the broken rod was not removed but instead, an auxiliary rod was installed adjacent to the broken rod.No further patient impact was reported.No additional information is available.
Additional Manufacturer Narrative
This report was initially submitted on 17 nov 2020; however, upon subsequent review of the report, it was noted it had not been successfully received by fda.Therefore, this report is being resubmitted.No device was returned for evaluation as it was left in-situ per surgeon's prerogative.A provided radiograph confirmed the reported fracture.It is unknown if the patient follow post-operative physical restrictions or suffered a fall.It is unknown if fusion had been achieved.Device lot information was not available; therefore, a production record review could not be performed.The root cause of the rod fracture is unknown but review of the provided radiograph identifies a large construct with double rod configuration above and below the fractured area, indicating excessive loading as the possible cause or contributor."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 include.Bending, fracture or loosening of implant component(s)." "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." should additional, relevant information be received, a supplemental report will be submitted.H3 other text : device remains in-situ.

• 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: geoffrey gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 17198352
• Report Number: 2031966-2020-00204
• Device Sequence Number: 20275659
• Product Code: NKB
• UDI-Device Identifier: 00887517581211
• UDI-Public: 887517581211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15460500
• 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: 10/19/2020
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male