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

Model Number	6951815
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation as it remains in-situ.Review of provided lateral radiographs confirmed the alleged event.The root cause can not be confirmed, however review of provided information and communication with surgical staff suggest patient bone quality may have contributed to the event.Labeling review: ".Contraindications - contraindications include, but are not limited to: 5.Patients with inadequate bone stock or quality." ".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: bending, fracture or loosening of implant component(s), loss of fixation, fracture of the vertebra." ".Warnings, cautions and precautions - 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.".
Event or Problem Description
On (b)(6) 2020 patient underwent a anterior lumbar interbody fusion procedure at l5-s1 levels.On (b)(6) 2020, while at the hospital the patient was walking and felt a "pop".X-rays reveled a screw back out and pars separation.On (b)(6) 2020, the second part of the procedure was performed, where the construct was backed up with percutaneous pedicle screws.Patient will continue to be monitored, for any further l5 screw movement.Reportedly, the patient is doing well after posterior stabilization.

• Brand Name: NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10422792
• Report Number: 2031966-2020-00162
• Device Sequence Number: 19568969
• Product Code: OVD
• UDI-Device Identifier: 00887517700827
• UDI-Public: 887517700827
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6951815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR