• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NUVASIVE, INC. NUVASIVE POLYAXIAL SPINAL SCREWS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNUVASIVE POLYAXIAL SPINAL SCREWS
Type of DeviceTHORACOLUMBOSACRAL 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 Key6805756
MDR Text Key83090755
Report Number2031966-2017-00108
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K121619
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
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 Treatment Data
Date Received: 08/18/2017 Patient Sequence Number: 1
-
-