Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
  • 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. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL Back to Search Results
Model Number 6790225
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 07/01/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No allegation of product malfunction reported.No product has been returned for evaluation as product remains in-situ.No x-rays were provided to confirm the alleged event.Labeling review: ".Potential adverse events and complications potential risks identified with the use of this system, which may require additional surgery, include: dural leak.".
 
Event or Problem Description
On (b)(6) 2015, a patient underwent an anterior cervical discectomy and fusion procedure.During procedure an incidental durotomy at c4-5 levels occurred.Duragen was applied prior to placement of interbody cage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COROENT INTERLOCK SYSTEM
Common Device Name
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk blvd
san diego CA 92121
MDR Report Key7603925
Report Number2031966-2018-00102
Device Sequence Number16541680
Product Code OVE
UDI-Device Identifier00887517361608
UDI-Public00887517361608
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K102547
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/14/2018
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 Physician
Device Model Number6790225
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2018
Initial Report FDA Received Date06/14/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-