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

Model Number 11102255

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Misassembled During Installation (4049)

Patient Problem Pain (1994)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received and product has not been returned for evaluation.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.Further, operative notes and/or immediate post-op radiographs were not provided for review of usage/technique to determine if the lock screw was adequately seated and the construct appropriately tightened during the initial procedure.A definitive root cause was unable to be determined with the information provided.There are warnings in the device labeling that this type of event can occur.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)." ".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.All lock screws should be final-tightened with the counter-torque and torque t-handle." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a posterior fixation procedure.Subsequently, during a routine follow up approximately three (3) months later, it was identified that the lock screw of the rod-to-rod connector at l4/l5 had loosened.The patient noted experiencing symptoms of pain in addition to the feeling of loose components.A revision procedure was performed approximately six (6) months after the initial procedure to remove and replace the connector and lock screw.No further patient impact was reported.The patient is reported to be doing well post-revision procedure.No additional information is available.Report 2 of 2.

Manufacturer Narrative

The devices were received by nuvasive qa sd and the complaint was confirmed.The patient postoperative physical activity is unknown.The damage observed during examination suggest the closed lock screw was cross threaded disallowing proper lock down of the rod, as well the open lock screw observations suggest insufficient rod reduction during lock screw initiation, incomplete final torque to 90 in/lb resulting in subsequent lock screw back out.Though i am unable to determine what took place first the findings indicate the root cause of the issue as a procedural error related to misalignment cross threading, incomplete lock screw final tightening and or incomplete rod normalization and interference, which can be the consequence of surgical technique but may be the result of anatomical challenges of the patient.Review of the device history records for both devices notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.No additional investigation required.Labeling review: ".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." ".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." ".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." ".Step 4: rod & lock screw insertion after cutting the rod to length and contouring, place the rod into the implants and insert lock screws to provisionally secure the rod.1.The rod holder may be used to assist in placing the rod (fig.13).Use the longitudinal lines to ensure the rod is placed in proper sagittal alignment.To release the rod, depress the button at the center of the proximal ratchet.2.The multi-load lock screw starter can be used to deliver up to eight lock screws when no reduction is required (fig.14).O turn the gray central sleeve counterclockwise to fully retract the distal sleeve.O insert the distal end into the lock screw (5.5 or 6.0 mm, cannulated only), ensuring the silver side of the lock screw is facing up.O once the lock screws have been loaded, turn the central sleeve clockwise to compress the lock screws together.Do not hold onto the central sleeve during lock screw delivery, as this will cause the distal sleeve to retract, preventing adequate compression of the lock screws.O after delivery of each lock screw, rotate the central sleeve clockwise until resistance is felt prior to delivering the next lock screw.Tip: the lock screws on the multi-load lock screw starter must be compressed by the central sleeve after delivery of each lock screw to ensure proper engagement into the tulip.3.If reduction is required, use the lock screw starter to load a single lock screw and deliver down the reducer of choice." ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument (reference surgical technique)." ".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.The bulleted portion of the nose of the rod and the faceted portion of the rod (where the inserter locks down on the rod) must extend fully outside of the most inferior or most superior tulip on the construct.The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct.All set screws should be final-tightened with the counter- torque and torque t-handle.Do not final-tighten through compression instruments in the set, as the rod may not be able to normalize to the tulip.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15577425
• MDR Text Key: 301558091
• Report Number: 2031966-2022-00198
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143684
• 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: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11102255
• Device Catalogue Number: N/A
• Device Lot Number: TU8863
• 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: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 13550000 LOCK SCREW
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 90 KG