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

Model Number 6308860006P2

Device Problem Fracture (1260)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to nuvasive for evaluation and the complaint was confirmed.Review of the returned device found the implant was fractured at the inserter connection point and is consistent with excessive force.Review of the complaint report identified the fracture took place during implantation and the disc space was noted by the surgeon to be narrow.The root cause of the failure is considered to be the result of excessive force during impaction and is considered to be the result of technique and implant selection.No additional investigation required.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 (b)(6).You may also email: (b)(6)." ".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 #: (b)(4) for non-sterile implants and #: (b)(4) for sterile implants." (b)(4).

Event Description

It was reported on (b)(6) 2022 a patient underwent an extreme lateral interbody fusion procedure from l2-s2.During the insertion of the vertebral spacer into the l3-l4 disc space the implant fractured.All fragments were retrieved and an alternate implant was utilized.It was noted that the patients intervertebral space was narrow.No adverse patient consequences were reported.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR IMPLANTS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14988934
• MDR Text Key: 304463103
• Report Number: 2031966-2022-00123
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517661173
• UDI-Public: 887517661173
• 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
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6308860006P2
• Device Lot Number: NU12227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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
• Patient Age: 75 YR
• Patient Sex: Male