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

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

Patient Problems Cyst(s) (1800); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation as no product malfunction was alleged.No root cause can be identified at this time.

Event Description

During literature review it was identified that between the dates of march 2018 and march 2020, 105 patients underwent lateral interbody.It was identified that a patient experienced pain and decision was made to return to operating room on postoperative day three.Upon right l4 laminectomy and facetectomy a large intraforaminal facet cyst was encountered and removed.It is unknown if nuvasive¿ s products were used with this alleged case as multiple manufactures were referenced in article.

• Brand Name: ALIF INTERFIXATED SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: maria torres ; 101 enterprise dr.; aliso viejo, CA 92656
• MDR Report Key: 10103682
• MDR Text Key: 193292780
• Report Number: 2031966-2020-00114
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2020
• 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: 42 YR