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

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2023

Event Type  Injury  

Event Description

A t3 to ilium fixation procedure was performed on (b)(6) 2023 in which pulse system navigation and reline open fixation hardware was used.During the procedure, at unknown spinal levels, navigation appropriately indicated that two (2) pedicle screws selected for use were too long and two (2) pedicle screw trajectories were too lateral.However, the surgeon proceeded and placed the screws despite the navigation readings.Radiographic images taken after implantation confirmed that the screws placed were not entirely implanted in bone.The surgeon opted to not replace or revise the screws at that time and concluded the procedure.Three days after the initial procedure, (b)(6) 2023, a revision surgery was performed where the malplaced screws were removed and new screws were placed in correct positions and trajectories.No reports of clinical signs, symptoms, or harm were received from the patient.

Manufacturer Narrative

No radiographs of the malplaced screws were provided; however, an on-site company representative attending the case was able to confirm malposition of four (4) pedicle screws.As per the information collected, the associated stereotactic surgical navigation system accurately indicated that the depth of two (2) pedicle screws and the trajectory if two (2) pedicle screws would be malpositioned if placed according to the surgical plan.The surgeon opted to proceed despite navigation readings.Additionally, the surgeon opted to not replace or revise the screws at that time and concluded the procedure and instead conducted a revision surgery on a later date.Based on the information obtained, the root cause of the reported revision surgery was a use error.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." "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." device not returned to manufacturer.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16437082
• MDR Text Key: 310167786
• Report Number: 2031966-2023-00031
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K223181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• 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
• Patient Sequence Number: 1
• Treatment: PULSE III SYSTEM
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose