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

Model Number 16171111

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

Screw implanted on (b)(6) 2022 and found on follow up not seated on shank, surgeon stated may not have fully seated tulip on shank.Replaced (b)(6) 2023.

Manufacturer Narrative

The device was received by nuvasive and the complaint was confirmed to be a tulip separation.Examination found a lack of impact or contact marks up inside the inner surface of the connector head expected if modular screw was fully assembled per instruction.Additionally the inferior end of the connector incurred a 4mm wide contact smear next to the shank head entry port but unable to determine if the result of shank head contact after or before the in-situ assembly.Review of the reported event, contact markings and noted the lack of contact damage to the tulip port, load ring and split ring indicates the modular tulip was not fully seated onto the shank head disallowing complete engagement and retention of the shank head resulting in the subsequent detachment once load was applied.Note the contact mark on the inferior side may indicate boney obstruction contact during placement that may have hindered completed assembly.The root cause of the reported event is considered an unintended procedural error related to insufficient modular screw assembly.No additional investigation required.Manufacturing review: review of the device history record notes no material non-conformance¿s, 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.Labeling review: contraindications: contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice." 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." "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.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials.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.Corrosion of the implant can occur.Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion.Placing dissimilar metals in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants.Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other.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.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)(6).You may also email: (b)(6).

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE 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: geoffery gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16651478
• MDR Text Key: 312596925
• Report Number: 2031966-2023-00057
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517587497
• UDI-Public: 887517587497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223181
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16171111
• Device Lot Number: JP24595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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
• Treatment: 13550000 LOCK SCREW.; UNKNOWN ROD.
• Patient Sex: Prefer Not To Disclose