• 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 ADJUSTABLE VERTEBRAL BODY REPLACEMENT 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 ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM Back to Search Results
Model Number 5962366
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Date 04/01/2013
Event Type  Injury  
Event Description

Following implantation of a vertebral body replacement (vbr) device spanning the c3-c7 spine levels, the patient reported increasing pain. The vbr was noted to have subsided into the c3 vertebral body approximately six weeks after surgery. Revision surgery was performed in which the anterior cervical plate was removed and vbr was replaced. The anterior cervical plate was replaced with posterior pedicle screw fixation. No malfunction of the device is known to have occurred.

 
Manufacturer Narrative

(b)(4). The product has not been returned for evaluation and may have been discarded at the user facility. Root cause of the event has not been identified; however, the reported event is consistent with patient-related factors as a contributor. Labeling review: "contraindications include but are not limited to:. Patients with inadequate bone stock or quality. " "potential risks identified with the use of this system, which may require additional surgery, include:. Fracture of the vertebra. ".

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
Type of DeviceNUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
Manufacturer (Section D)
NUVASIVE, INC.
7475 lusk blvd
san diego CA 92121
Manufacturer (Section G)
NUVASIVE, INC.
7475 lusk boulevard
san diego CA 92121
Manufacturer Contact
paul holbrook
7475 lusk blvd
san diego, CA 92121
8583205285
MDR Report Key4943517
MDR Text Key20152564
Report Number2031966-2015-00041
Device Sequence Number1
Product Code MQP
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5962366
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/17/2015
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/16/2015 Patient Sequence Number: 1
-
-