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

Model Number 13550000

Device Problems Detachment of Device or Device Component (2907); Expulsion (2933)

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

Event Date 04/27/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 a patient underwent a posterior fixation procedure from l2-s with a competitors screw being placed at s2.The surgery was completed without issue and the surgery was completed.The same day following the surgery radiographs were taken and it was discovered the left l5 lock screw had dislodged and was loose in the patient.That same day a revision occurred and the dislodged lock screw was retrieved and replaced with a new lock screw.There were no additional adverse consequences to the patient as a result of the failure.The patient is reported to be doing well post revision.

Manufacturer Narrative

The device was returned to nuva japan who provided photos and evaluation results confirming the complaint.Torque handle information was provided and the torque handle utilized in the case was found to be performing within required specifications.Examination of the photos of the expulsed lock screw revealed contact markings on the inferior side of the lock screw are consistent with rod contact and contouring challenges, as well as thread damage (peeled) consistent with incomplete rod reduction.Review of the reported event identified that during the index procedure three other lock screws were utilized, damaged and replaced as a result of rod contouring challenges and damage associated with the connection to another manufactures devices.Review of all the information received suggest the root cause was the result of inadvertent surgical error related to insufficient rod contouring, excessive upward force and possibly the result of the incorporation of another manufactures device.No additional investigation can be completed.Label review ".Potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries.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.".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." ".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." ".Compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." ".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." ".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.".

Event Description

N/a.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No device was returned to the nuvasive product monitoring team for evaluation; the reported lock screw failure was confirmed by review of a photograph of the device.The photograph depicted damage to the distal starting thread of the lock screw and off-center abrasions on the inferior surface, indicating possible cross threading during lock screw initiation secondary to off-axis interference with the rod caused by incomplete rod normalization.No operative notes and/or radiograph images were provided for review of usage/technique.A review of manufacturing records was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided, however is likely the result of an unintended use error caused by incomplete rod reduction/ normalization resulting in failure to final tighten the lock screw.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: 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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17004206
• MDR Text Key: 316125958
• Report Number: 2031966-2023-00118
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

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: 13550000
• Device Lot Number: N342951
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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
• Patient Sex: Male