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

Model Number 6309855006P2

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

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

Event Date 09/15/2022

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, a titanium spike disassembled from the interbody assembly.The interbody was retrieved; however, the disassembled spike was unable to be found and was retained by the patient.A new 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

The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, no operative notes and/or radiograph images were provided for review of usage/technique.A review of device manufacturing records was performed and no discrepancies were found that would have contributed to the reported event.A definitive root cause was unable to be determined with the information provided.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".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.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." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) 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 but the complaint was not confirmed as disassembled, but rather a damaged marker pin.Examination revealed no fractures, cracks or missing marker pins.The distal left marking pin is raised cranially approximately 1 mm from standard position and the caudal side of the pin tip is ground off flat.The damage observed is consistent with an oversized implant being forced into too small of a disc space in an attempt to distract the space with the cage, where it appears anatomical bone contact ground down the tantalum marker and forced the pin upwards.The damage observed is considered the result of a procedural error related to implant selection and excessive force.No pieces are missing or fractured and this event is actually no longer a reportable event, 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." ".Pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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 #(b)(4) for non-sterile implants and #(b)(4) for sterile implants." new and updated information in sections: b4, d4, d9, g3, g6, h2, h3, h4, h6, and h10.

Event Description

New or updated information listed in section 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: 15569774
• MDR Text Key: 306988906
• Report Number: 2031966-2022-00197
• 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: 01/10/2023

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: N331459
• 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: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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 Sex: Female