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

Model Number	16026545
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11465580
• Report Number: 2031966-2021-00041
• Device Sequence Number: 19713527
• Product Code: NKB
• UDI-Device Identifier: 00887517556639
• UDI-Public: 887517556639
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 16026545
• Device Lot Number: N279472
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR