MAUDE Adverse Event Report: NUVASIVE INCORPORATED NUVASIVE COROENT THORACOLUMBAR IMPLANTS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC

Model Number 6309855006

Device Problem Fracture (1260)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

No device was returned to nuvasive for evaluation however photos were provided confirming the alleged complaint.Review of the information provided found the fracture took place during implantation into the disc space.The root cause of the failure is unknown but the information provided as well as of review of similar events suggests the failure to be a result of excessive force during impaction and/or an attempt to distract the disc space with the device and is considered to be the result of technique and implant selection.No additional investigation required.Label review: "warnings, cautions 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." "all implants should be used only with the appropriately designated instrument (reference surgical technique)." "pre-operative warnings - care should be used in the handling and storage of the coroent implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments." " care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

Event Description

On (b)(6) 2022, a patient underwent extreme lateral interbody fusion procedure on unknown levels of the spine.During the procedure while inserting a spacer in between the l3 and l4 the cage fractured at the inserters engagement point.All of the fractured component were removed from the patient, a second implant was utilized and the surgery was completed with no adverse consequences to the patient.

Event Description

Corrected information listed on section h10.

Manufacturer Narrative

The device was received by and the complaint was confirmed.Review of the returned device found it fractured at the inserter connection feature.Review of the reported event identified the device fractured during placement while attached to an inserter.The disc space must be properly trialed and distracted in order to prevent damage or fracture of the implant during impaction.Breakage may occur due to off-axis forces that promote twisting of the implant to maximize distraction of the disc space in an attempt to restore proper spacing of the vertebral bodies, off-axis impact with the mallet, micro motion at the implant / inserter interface if the implant cage is not fully threaded or over tightened onto the inserter.Root cause is considered to be related to technique, implant selection and excessive off axis force.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: ".Warnings, cautions 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.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." ".Compatibility: all implants should be used only with the appropriately designated instrument (reference surgical technique)." ".Pre-operative warnings: 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 (b)(6).You may also email: (b)(6).This instructions for use document is intended for the us market only.For ous instructions for use, please refer to document #(b)(4) for non-sterile implants and #(b)(4) for sterile implants." (b)(4).Corrected information found in sections: b4, d4, d9, d10, g6, h2, h3, h4, h6, h10.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR IMPLANTS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• 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: 16199796
• MDR Text Key: 308952140
• Report Number: 2031966-2023-00006
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517273390
• UDI-Public: 887517273390
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150994
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6309855006
• Device Lot Number: NU11791
• 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: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• 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: COROENT XL INSERTER
• Patient Age: 53 YR
• Patient Sex: Male