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

Model Number	24017545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2031966-2022-00072
• Device Sequence Number: 17228343
• Product Code: NKB
• UDI-Device Identifier: 00195377041715
• UDI-Public: 195377041715
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/04/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose