MAUDE Adverse Event Report: NUVASIVE, INC. UNKNOWN NUVASIVE DEVICE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 10/20/2023

Event Type  Injury  

Manufacturer Narrative

D1: it is unknown what nuvaisve product line was involved in the blood loss event: reline, coroent li, or coroent lm.The reported event was unable to be confirmed due to limited information received concerning this event.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 manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.It should be noted that review of mri and ct images at the hospital found no evidence of vascular damage caused by the pedicle screws or surgical devices.Labeling review: "residual risks and potential side effects: as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels, spinal cord or peripheral nerves rarely, some complications may be fatal." "warnings, cautions and precautions: be careful not to plunge or insert the rasps past the stop, as this may lead to damage of the nerve roots and vascular structures that are ventral to the facet joint." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the potential risks of the surgery." "intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent an initial three (3) level posterior lumber interbody fusion from l3 to s1 with posterior fixation from t11 to s2ai.There was reported to be no major problems during the procedure; however, the total intraoperative blood loss was 2480 cc.Blood transfusion was provided to the patient; however, the volume or timing of the transfusion is unknown.After closure of the incision, the patient went into cardiopulmonary arrest in the operating room.Cardiac massage was performed and the heartbeat resumed; however, the patient remained unconscious during an approximate 3 hour wait to transfer the patient to another facility.Mri and ct images were obtained at the facility where the patient was transferred and no vascular damage caused by the pedicle screws or surgical devices was confirmed.The surgeon believed a hemorrhagic shock occurred.As of the following day, the patient had not yet regained consciousness.No further information was available.

• Brand Name: UNKNOWN NUVASIVE DEVICE
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 18136975
• MDR Text Key: 328110912
• Report Number: 2031966-2023-00262
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR
• Patient Sex: Female