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

Model Number 14514530

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that the patient underwent a posterior fixation procedure.Subsequently, on an unknown date, it was identified that the polyaxial tulip feature of the pedicle screw separated from the screw shank post operatively.There were no reports of any fall or other traumatic event experienced by the patient that may have attributed to the event.The patient underwent a revision procedure approximately six (6) months later to revise the implant.No further patient impact was reported.

Manufacturer Narrative

The investigation is currently in process.Once the investigation has been completed, a supplemental report will be submitted.

Manufacturer Narrative

The product was received by nuvasive and the complaint was confirmed.Evaluation of data and the returned devices indicate clinical loads on this construct exceeded the mechanical strength of the implants and though no definitive root cause could be determined the information received and identified suggests rod contouring, reduction and normalization difficulties related to patient anatomical challenges lead to incomplete lock screw final torque down, excessive loading and subsequent failure.No additional investigation can be completed.Labeling 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, 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.Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines." "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." "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." "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.Cross connectors are designed specific to the rod diameter and cannot be used on the tapered section of tapered rods.If using cross connectors on tapered rods, only attach them on constant diameter rod sections.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.".

Event Description

Updated information found on h10.

• Brand Name: NUVASIVE RELINE SMALL STATURE 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 ; 8583448112
• MDR Report Key: 14881480
• MDR Text Key: 295122441
• Report Number: 2031966-2022-00116
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517767653
• UDI-Public: 887517767653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170126
• 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,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14514530
• Device Catalogue Number: N/A
• Device Lot Number: JP17867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2019
• 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: 13450000 RSS LOCK SCREW, 4.5/5.0MM.
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose