MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE LUMBAR INTERBODY IMPLANTS; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 7160950P2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.No x-rays were provided to confirm the alleged event.No allegation of product malfunction reported.Product remains in-situ.

Event Description

On (b)(6) 2017 a patient underwent an extreme lateral interbody fusion procedure on l1-l5 levels.Upon insertion of the cage in the l4/5 levels, a fracture of l4 was detected in the frontal plane.Due to gradual bleeding from the fractured vertebra, the doctor packed hemostatic materials.The other two cages were placed and posterior fusion at t4-s2ai levels and posterior lumbar interbody fusion at l5/s levels were performed using another manufacturer's implants.

• Brand Name: NUVASIVE LUMBAR INTERBODY IMPLANTS
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 7134091
• MDR Text Key: 95367798
• Report Number: 2031966-2017-00185
• Device Sequence Number: 1
• Product Code: MAX
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 7160950P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• 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): Required Intervention
• Patient Age: 80 YR