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

Model Number	16026545
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10587130
• Report Number: 2031966-2020-00187
• Device Sequence Number: 2655953
• Product Code: NKB
• UDI-Device Identifier: 00887517556639
• UDI-Public: 887517556639
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 16026545
• 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: 08/27/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1