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

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.

• 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 Key: 7811422
• MDR Text Key: 118089917
• Report Number: 2031966-2018-00133
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170592
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/23/2018
• 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
• Date Manufacturer Received: 07/29/2018
• 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 Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR