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

Model Number 5181308P2

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  malfunction  

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, 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 were found.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.

Event Description

During a procedure, after the cage was implanted at l4/5, the cage experienced a fracture at the lateral proximal wall of the implant, fracturing into two pieces.The two pieces of the peek portion of the cage were recovered with the help of a surgical microscope; however, one of the cage's tantalum markers separated from the cage body and could not be located, and therefore remained in the patient's disc space.No further patient impact was reported and the patient is reported to be fine.

Manufacturer Narrative

The device was received by nuvasive and confirmed the device was fractured.Examination revealed the peek material fractured at the inserter attachment feature shearing off the superior side of the feature, additionally deep gouges where viewed between each of the directional attachment holes.All 5 tantalum marks were accounted for so no fragments or pieces were left in the patient.Note the inserter was not returned and assumed to be properly functioning as it was utilized in placing the replacement.Review of the returned device and provided procedural information indicated the root cause to be the result of off angled (caudal) excessive force during implant impaction and likely the result of insufficient space prep/distraction or oversized implant/improper trialing and considered the consequence of surgical technique.No additional investigation required.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.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.For coroent anterior tlif implants, do not position inserter past 90° with respect to the implant.Hyper angulation during impaction may result in implant disengagement." ".Pre-operative warnings: 3.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.4.Refer to cleaning and sterilization instructions below for all non-sterile parts.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 (b)(6).

Event Description

Updated information listed in section h10.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR INTERBODY
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 15520168
• MDR Text Key: 306336890
• Report Number: 2031966-2022-00191
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517733009
• UDI-Public: 887517733009
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140319
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5181308P2
• Device Catalogue Number: N/A
• Device Lot Number: ML3163
• 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: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2019
• 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: 63 YR
• Patient Sex: Female