MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 16026545

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ, but provided radiograph confirmed alleged event.Even though root cause cannot be confirmed, review of the reported information identified a surgical technique may have contributed to alleged event.No revision procedure is planned at this time.Labeling review: "warning: care should be taken to insure that all components are ideally fixated prior to closure." "pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "note: check both reduction extensions after removal for the black lasermark at the distal end of the reduction extension to ensure the reduction extension has broken off at the correct spot note: be sure the lock screw is fully seated and the rod is fully locked down." device still in-situ.

Event Description

On (b)(6) 2020, a patient underwent spinal procedure.On (b)(6) 2020, radiographs indicate the mass reduction screw did not break off correctly.As per reporter, it has not been decided if patient will undergo a revision procedure.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: virnalisa ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 10587130
• MDR Text Key: 208576383
• Report Number: 2031966-2020-00187
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517556639
• UDI-Public: 887517556639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• 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: 09/25/2020

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
• Device Operator: Health Professional
• Device Model Number: 16026545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/25/2020
• 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