MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE POLYAXIAL SPINAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombosis (2100)

Event Date 07/24/2017

Event Type  Death  

Manufacturer Narrative

No allegation of product malfunction.No product will be returned for investigation.Labeling review potential adverse events and complications ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal.".

Event Description

On (b)(6) 2017, a patient underwent posterior percutaneous spinal fixation at the t9-s2 levels.At the time of closing the surgical incisions, patient's oxygen saturation level dropped and the patient went into cardiac arrest state.Patient was treated by an anesthesiologist but did not recover.No allegation of product malfunction.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 6805756
• MDR Text Key: 83090755
• Report Number: 2031966-2017-00108
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR