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

Model Number	10000607
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were discarded by the user facility so no evaluation can be completed, however radiographs provided confirmed the complaint.Review of the provided radiographs identified 10-11mm of k-wire protruding from the bottom of the two screws placed in vertebral bodies t12 and t11.Review of the radiographs and provided information identified what appears to be an inadvertent surgical error related to excessive screw advancement prior to k-wire removal.Radiographs confirmed the k-wire to be fixed in the bone and inside the screw shank and is not a concern for migration.Labeling review: 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: early or late infection.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), metal sensitivity or allergic reaction to a foreign body, infection." "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.K-wire should be removed when screw has reached the posterior wall of the pedicle to avoid kink in tip.Ensure the k-wire is not advancing as the path is created over the k-wire.Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire." "mri safety information: the reline system has not been evaluated for safety and compatibility in the mr environment.It has not been tested for heating, migration, or image artifact in the mr environment.The safety of the reline system in the mr environment is unknown.Scanning a patient who has this device may result in patient injury." "pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at (b)(6).You may also email: (b)(6)." (b)(4).P-12/2018.H3 other text : no device returned; discarded by user.
Event or Problem Description
A spinal procedure was conducted at t11/13.During screw implantation at t12, a piece of the k-wire about 9-10mm in length remained in the vertebrae.Then at t11 this occurred again with a piece about 10mm in length.No pieces were retrieved.No patient injury or consequences reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of a photograph of the fractured k-wire and radiographs showing the k-wire tip within the vertebral body, anterior to the tip of the pedicle screw.No device was returned to nuvasive qa for evaluation; further, operative notes were not provided for review of usage/technique.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided; however, may have resulted from interference between the tip of the screw and the k-wire in-situ.Labeling review: "¿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." k-wire should be removed when screw has reached the posterior wall of the pedicle to avoid kink in tip.Ensure the k-wire is not advancing as the path is created over the k-wire.Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire.".Pre-operative warnings: implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and 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
N/a.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17473863
• Report Number: 2031966-2023-00162
• Device Sequence Number: 7269600
• Product Code: NKB
• UDI-Device Identifier: 00887517512307
• UDI-Public: 887517512307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 10000607
• 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: 07/16/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10000409.
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native, Asian