MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE LUMBAR INTERBODY IMPLANTS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 6308845006

Device Problems Installation-Related Problem (2965); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation as product remains in-situ.Radiographic images confirm the alleged event.Label review: ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include.Fracture of the vertebra." ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." product remains in-situ.

Event Description

On (b)(6) 2019, the patient underwent extreme lateral interbody fusion procedure using coroent xl from the l2 to l5 vertebral levels.On (b)(6) 2019, the secondary portion of the extreme lateral interbody fusion procedure was performed using reline from the th10 to s2ai vertebral levels.Images taken after the secondary surgery revealed vertebral fractures on the anterior sides of the l4 and l5 vertebral bodies.There is no revision procedure planned as the patient is asymptomatic.

• Brand Name: NUVASIVE LUMBAR INTERBODY IMPLANTS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 9577671
• MDR Text Key: 174622011
• Report Number: 2031966-2020-00005
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517272959
• UDI-Public: 887517272959
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6308845006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR