MAUDE Adverse Event Report: NUVASIVE INC BASE INTERFIXATED TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 6955171

Device Problem Migration (4003)

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

Event Date 11/14/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to nuvasive, but photographs provided confirmed the complaint.It was reported that proper torque was applied during the implantation of the screws.Examination of the photographs taken during the removal identified the locking mechanism set screw on both bolts was not activated and still in the unlock position indicating an unintended use error and failure to lock the bolt into the interbody cage.Should the device return and more information be given an additional file will be reported.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 components." "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.When implanted at two contiguous levels, the base interfixated system must be implanted in the same orientation to prevent screw impingement or potential bone fracture.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.It is important to select the appropriate length base interfixated screw and confirm trajectory under intraoperative fluoroscopy in order to avoid potential screw impingement.If fewer than the maximum number of screws accommodated by the device are used, then the system is intended to be used with additional supplemental fixation (cleared by the fda) for use in the lumbar spine.Care should be taken to ensure that all components are ideally fixated prior to closure." "pre-operative warnings:.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "post-operative warnings.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)(6).

Event Description

On (b)(6) 2023 a patient underwent a lumbar interbody procedure at l4/5.It was reported that the two lateral fixation screws backed out of the interbody cage at l4/5, requiring a revision surgery approximately eight months after implantation.The central fixation screw remained in place, as intended, and the surgeon was satisfied with the placement and stability of the interbody cage and therefore left the interbody cage in place.No further patient impact was reported.Upon removal, it was noted one of the fixation screws had a bent tip and may not have fully penetrated the bone for proper fixation; however, it was reported that during the implantation procedure, the screws had been fully inserted with the appropriate torque being applied to secure the screws.No additional information is available.

Event Description

N/a.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: a3, b1, b2, d2, g4, h1 additional information: d9, h3, h6, h10 radiographs of the reported issue were provided and the event was confirmed as the interbody was visible within the disc space and one of the fixation screws could be seen backed out and protruding anteriorly out of the disc space.Further, the bolt locking mechanism appeared to be sitting proud in the radiograph image, possibly in the "unlock" position.The complaint device was returned to nuvasive and evaluation identified damage to the distal tip and proximal thread form, indicating possible difficulty during insertion and an off-axis trajectory of the screw resulting in interference with the interbody.Additionally, no damage or any contact abrasions were apparent on the locking mechanism set screw and it was in the unlock position upon receipt; suggesting the bolt was never locked into the interbody cage.A review of the device history record was performed and no discrepancies relevant to the reported event were found.The root cause of the reported issue was determined to be an unintended user error by failure to appropriately seat and lock the fixation bolt.Labeling review: "¿potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." ".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.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.Care should be taken to ensure that all components are ideally fixated prior to closure." ".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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: BASE INTERFIXATED TITANIUM SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• 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: 18275465
• MDR Text Key: 329843895
• Report Number: 2031966-2023-00284
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170592
• 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,Followup
• Report Date: 02/09/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6955171
• Device Lot Number: BB0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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: BASE INTERBODY CAGE.
• Patient Outcome(s): Hospitalization
• Patient Sex: Male