MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE CERVICAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 3904012

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 a patient underwent a posterior cervical fusion procedure on unconfirmed levels of the spine and the surgery was completed without issue.On the following day of (b)(6) 2023 radiographs discovered a screw tulip head on the left side of the construct had disassociated.The patient experienced no adverse consequences as a result of the device issue.A revision occurred on (b)(6) 2023 where the damaged screw, set screw and left side rod were replaced.The revision was completed without issue and the patient has been discharged and is doing well.

Manufacturer Narrative

No product was received at this time but three radiographs were provided confirming alleged incident.The root cause of the event cannot be confirmed but review of the radiographs and event description suggests extreme angulation and excessive force with the split ring placed at the apex of the angulation and/or physical damage to the screw components during implantation or shank adjustment.No additional investigation can be completed at this time.".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, caution and precautions - the subject device is intended for use only as indicated.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." ".Correct mating of system components should also be considered at each component interface, such as screwdriver-screw, rod-tulip rod slot, etc.Incorrect or inadequate mating of such components may result in further surgical delays or compromised construct integrity.".

Event Description

New and updated information listed on h10.

Manufacturer Narrative

The device was returned for evaluation and radiographs provided confirmed the reported event.Review of the provided radiographs confirmed the screw shank separated from the tulip assembly, also noting that several bilateral screws placed including the separated one appear to be hyper angulated.Examination of the returned screw noted the split ring was enlarged and a substantial gouge on the outside surface of the tulip no other damage observed.It is unknown if a counter torque was utilized during the final lock screw tightening.No definitive root cause could be determined however review of the provided information and similar cases suggest extreme angulation of the shank in relation to the tulip head combined with excessive loading resulting in prying force and subsequent separation.No additional investigation can be completed.Manufacturing review: review of the device history record 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.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(s), loss of fixation."."warnings, caution and precautions the subject device is intended for use only as indicated.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.".".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.Correct mating of system components should also be considered at each component interface, such as screwdriver-screw, rod-tulip rod slot, etc.Incorrect or inadequate mating of such components may result in further surgical delays or compromised construct integrity.Based on the fatigue testing results, when using the nuvasive reline cervical system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc.Which may impact on the performance of the system.".".Pre-operative planning prior to implantation of posterior cervical lateral mass and pedicle screw spinal systems should include review of cross-sectional imaging studies (e.G., ct and/or mri imaging) to evaluate the patient's cervical anatomy including the transverse foramen and the course of the vertebral arteries.If any findings would compromise the placement of lateral mass or pedicle screws, other surgical methods should be considered.In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.".".Care should be taken to insure that all components are ideally fixated prior to closure."."compatibility.All implants should be used only with the appropriately designated instrument (reference surgical technique)¿."."pre-operative warnings use of cross sectional imaging (i.E., ct and/or mri) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine.The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement.In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.3.Care should be used in the handling and storage of the reline cervical implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the reline cervical implant from its packaging.Inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the reline cervical implants if there is any evidence of damage.5.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 at.".

• Brand Name: NUVASIVE RELINE CERVICAL SYSTEM
• Type of Device: POSTERIOR CERVICAL 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: 17503106
• MDR Text Key: 321276516
• Report Number: 2031966-2023-00167
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00195377068750
• UDI-Public: 195377068750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221388
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3904012
• Device Lot Number: TZ01547
• 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: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 68 KG