MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 1567869

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

No device was returned for investigation and no radiographs could be provided confirming the alleged fault.Review of the reported event identified the bleeding, shim and retractor loosening occurred as a result of inadvertent contact while trialing indicating the root cause as a result of an unintended use error.Label review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery; damage to blood vessels." "complications to the patient may include, but are not limited to: damage to soft tissue." "intra-operative warnings; it is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient." "to minimize the risk of damage to nerves and segmental vessels & creation of psoas hematoma, the following 4 steps are advised in techniques where fixation shims are used.Identify where the screw will engage the spine.Visually check for nerves and segmental vessels.Test for nerves with the nvm5 ball-tip probe.Place bone wax following removal of the fixation shims to minimize the risk of psoas hematomas." device not returned.

Event Description

On (b)(6) 2021 a patient underwent a lateral interbody fusion procedure from l2 to l5.During the procedure when the trial was being inserted at l4-l5 the shim reportedly came loose and the retractor dislodged, bleeding was observed and then stopped.Once the bleeding was controlled the cages were implanted at l2 through l4.L4 to l5 was reattempted and the bleeding resumed when the retractor was placed.The damaged vessel could not be identified by mri but hemostasis was completed so the physician decided to discontinue l4 to l5.The amount of bleeding was reported around 640cc.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 13012030
• MDR Text Key: 287279793
• Report Number: 2031966-2021-00187
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517218124
• UDI-Public: 887517218124
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203201
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1567869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 39 KG