MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE RELINE CERVICAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 3900301

Device Problem Disconnection (1171)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation, but radiograph provided confirmed the complaint.The patient's post-op physical activity is unknown.It is unknown if the patient suffered a fall.Torque handle information or if the surgeon utilized hand tightening is unknown.Total length and location of construct was not provided.Radiographic review identified what appears to be an extension of an existing construct where two vertebral bodies were left unfixed with extensive rod length spanning the gap and connected with two in-line connectors.Review of all the received information suggests insufficient torque applied to lock screw during index procedure, insufficient fixation and excessive loading and or excessive post-operative physical activity as likely cause or contributors to the event.No additional investigation can be completed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." "warnings, cautions and precautions the safety and effectiveness of this device has not been established for use as part of a growing rod construct.This device is only intended to be used when definitive fusion is being performed at all instrumented levels.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.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.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.Care should be taken to insure that all components are ideally fixated prior to closure." "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." "pre-operative warnings only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "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." "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)(4).You may also email: (b)(4).

Event Description

On (b)(6) 2023 a spinal procedure was conducted.On an unknown date it was discovered that the rod pulled out of the closed in-line connector as the patient felt the rod pop out.No patient injury was reported.On (b)(6) 2023 a revision surgery was conducted where the in-line closed connector was removed.No information provided as to what was done to repair it and no information on patient activity.

• Brand Name: NUVASIVE RELINE CERVICAL SYSTEM
• Type of Device: POSTERIOR CERVICAL 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17447288
• MDR Text Key: 320631794
• Report Number: 2031966-2023-00158
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00195377068132
• UDI-Public: 195377068132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221388
• 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: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3900301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2023
• 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: UNKNOWN ROD
• Patient Sex: Prefer Not To Disclose