MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 16026545

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

No product malfunction alleged.Surgeon noted the patient has a pacemaker and is on dialysis.No root cause of the cardiopulmonary arrest could be determined but it likely due to the preexisting patient factors,.The patient recovered and was observed in the operation room until the their condition became stable.The patient is currently well.".Contraindications include, but are not limited to:.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." pre-operative warnings.Only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.".

Event Description

A patient underwent a spinal procedure to address a rupture fracture.After collecting autologous bone from the ilium a pedicle screw was percutaneously inserted into l2.Subsequently the patient's blood pressure dropped, and cardiopulmonary arrest occurred.There was no abnormality in the image at the time when the pedicle screw was inserted.The pedicle screw was immediately removed, the incision was closed with surgical staples, and the patient was returned to the supine position for cardiac massage.The operation was discontinued and is now rescheduled on another day.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: dean lucas ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 11465580
• MDR Text Key: 239391379
• Report Number: 2031966-2021-00041
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517556639
• UDI-Public: 887517556639
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 16026545
• Device Lot Number: N279472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR