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

Model Number 8808500A

Device Problem Separation Problem (4043)

Patient Problem Pain (1994)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

Photograph provided of the screw confirmed the complaint.The patient's post-operative physical activity is unknown.It is unknown if the patient suffered a fall or if fusion took place.Review of the reported information suggests excessive loading and or post-operative physical activity as causes or contributors.No additional investigation can be completed at this time.Labeling review: ".Potential adverse events and complications : as with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components, loss of fixation, pain, discomfort or abnormal sensations due to the presence of the device." ".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.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.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.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." ".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.".

Event Description

On (b)(6) 2021 a posterior lumbar interbody fusion and posterior fixation was performed at l2/s2/ilium.On (b)(6) 2022 a revision surgery was conducted due to replace the tulip separation at s2/ilium and loose screws at l5 and s1.

Event Description

A list of updated information provided on h10.

Manufacturer Narrative

The device was received by nuvasive and the complaint was confirmed.No radiographs provided.No torque handle information provided.No bone quality report provided, and it is unknown if the patient experienced a postoperative fall.Summary of information received, and device examination indicates the lock screw was insufficiently locked down leading to rod micro motion, material deformation, loss of fixation, uneven excessive loading resulting in the subsequent tulip separation and considered the result of an inadvertent surgical error.No additional investigation required.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.Nonunion or delayed union.Pain, discomfort or abnormal sensations due to the presence of the device." ".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." ".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." ".Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis.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." ".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 +1-800-475-9131.You may also email: info@nuvasive.Com.This instructions for use document is intended for the us market only.For ous instructions for use, please refer to document #(b)(4) for non-sterile implants and #(b)(4) for sterile implants 9401385-en." adjusted information found on sections: b4, d4, d9, d10, g3, g6, h2, h3, h4, h6, h10.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15033062
• MDR Text Key: 304716361
• Report Number: 2031966-2022-00127
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517152220
• UDI-Public: 887517152220
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171894
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8808500A
• Device Lot Number: JK19869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2018
• 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: 8800000 LOCK SCREW
• Patient Age: 72 YR
• Patient Sex: Female