MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT THORACOLUMBAR INTERBODY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC

Model Number 6309855006P2

Device Problem Fracture (1260)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported that the patient underwent an initial one (1) level extreme lateral interbody fusion at l4/l5.During the procedure, as the surgeon inserted the interbody cage into the l4/l5 disc space using the slide instrumentation, the cage fractured at the proximal edge where it mates with the inserter.All pieces of the device were retrieved and a smaller sized interbody was implanted with no issues.No patient consequences have been reported as a result of the reported issue.No additional information is available.

Manufacturer Narrative

No device was returned to nuvasive for evaluation; the reported event was confirmed by review of a photograph of the retrieved piece.No operative notes and/or radiograph images were provided for review of usage/technique.A review of the device history record was performed and no discrepancies were found.A definitive root cause was unable to be determined with the information provided.However, potential causes of the type of cage fracture noted in the provided photograph are: twisting of the inserter/implant in an effort to maximize distraction of the disc space between vertebral bodies; or off-axis impact with the mallet; or micro motion at the implant / inserter interface if the implant cage is not fully threaded or over-tightened onto the inserter.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components." ".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.Care should be taken to ensure 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." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Manufacturer Narrative

The device was received by nuvasive and confirmed the complaint.Review of the complaint statement identifies the device fractured during implantation at the inserter connection after being hammered and required a smaller size implant.Review of the returned device confirmed a small piece of peek fractured off right at the attachment feature.The breakage observed is consistent with off-axis impact with the mallet and excessive force resulting from an over sized implant which would be considered the result of surgical technique and anatomical characteristics of the patient.No additional investigation required.Review of the device history record notes no material non-conformance, 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." ".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 (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 #9402700 for non-sterile implants and #9401726 for sterile implants." 9402012-en.

Event Description

Updated and new information listed on h10.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR INTERBODY
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• 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
• MDR Report Key: 15569810
• MDR Text Key: 307034629
• Report Number: 2031966-2022-00196
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517661265
• UDI-Public: 887517661265
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6309855006P2
• Device Catalogue Number: N/A
• Device Lot Number: N311025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Female