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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

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NUVASIVE, INC. NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
No product has been returned for evaluation.A review of x-rays films provided do not confirm alleged reported event.Labeling review: potential adverse events and complications potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra.Patient education: the patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.
 
Event Description
Patient underwent a construct extension from s5-l1 levels.Two weeks post-operatively patient was experiencing pain and sacral fracture was identified.Patient underwent a revision procedure to address the fracture.During the procedure it was identified a s1 screw was loose.As per reporter patient is doing well post revision procedure.
 
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Brand Name
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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 Key7811422
MDR Text Key118089917
Report Number2031966-2018-00133
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 08/23/2018
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/29/2018
Initial Date FDA Received08/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age65 YR
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