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

Model Number 6309845006P2

Device Problem Fracture (1260)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

No product was returned and no radiographs could be provided but a photo was provided of the explanted portion of the device.The root cause of the event is unknown but review of the information provided suggests the failure to be a result of excessive off angle forces or space prep difficulties.No lot code information was provided so a complete manufacturing review could not be completed.No additional investigation can be completed.Label review "warnings, cautions and precautions - 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." "based on fatigue testing results, when using the coroent xl interfixated system, the physician/surgeon should consider the levels of implantation." "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 +1-800-475-9131.You may also email: info@nuvasive.Com." "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." "handling of the sterile implant: open the packages carefully.Take suitable measures to ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used." "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 +1-800-475-9131.You may also email: info@nuvasive.Com.This instructions for use document is intended for the us market only.For ous instructions for use, please refer to document #9402700 for non-sterile implants and #9401726 for sterile implants." 9402012-en.

Event Description

On (b)(6) 2023 a patient underwent a extreme lateral interbody fusion procedure from l1-l5.While implanting the intervertebral spacer between l3 and l4 the implant fractured at the engagement point.The connection between the cage and the inserter appeared to have loosened during insertion of the cage.The fractured portion were retrieved while the surgeon opted to leave the fractured body in situ.The surgery was completed without issue and no reported adverse consequences to the patient.No radiographs could be provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.The reported event was confirmed by review of a photograph of the device, showing two (2) pieces of peek, including a portion of the proximal edge and one side of the threadform, that had been fractured off and separated from the remainder of the interbody.No device was returned to nuvasive qa for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A review of device 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, the fracture may have been caused by improper implant selection, insufficient disc prep, and/or excessive force used during insertion of the device.Labeling review: "¿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.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." ".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.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the coroent 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 coroent implants if there is any evidence of damage.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Packaging: packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive." ".Handling of the sterile implant: open the packages carefully.Take suitable measures to ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

N/a.

• 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18120775
• MDR Text Key: 328033172
• Report Number: 2031966-2023-00260
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517661241
• UDI-Public: 887517661241
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6309845006P2
• Device Lot Number: N347881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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 Age: 61 YR
• Patient Sex: Female