MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE-ONE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 24017545

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vertebral Fracture (4520)

Event Type  Injury  

Manufacturer Narrative

The reported event was confirmed by review of the radiographic image provided.No product was returned to nuvasive for evaluation as the device remains in-situ.Operative notes were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided.There are warnings in the device labeling that this type of event can occur: "potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra"."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".If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent an initial posterior fixation procedure on an unknown date.Subsequently, post-operative imaging obtained on an unknown date identified fracture of the patient's right pedicle at l4.The surgeon believes the fracture occurred during insertion of the screw.There is no intent to revise the implanted construct at this time and the patient has no adverse symptoms.No further patient impact was reported.

• Brand Name: NUVASIVE RELINE-ONE SCREW SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14004857
• MDR Text Key: 289667804
• Report Number: 2031966-2022-00072
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00195377041715
• UDI-Public: 195377041715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24017545
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose