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

Model Number	16191111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.The alleged event was confirmed by radiograph provided.Review of the reported event describes the reduction tab fractured off above the desired location.Labeling review: ".Note: check both reduction extensions after removal for the black laser mark at the distal end of the reduction extension to ensure the reduction extension has broken off at the correct spot." ".Tip: it is recommended to final tighten the lock screws prior to breaking off the reduction extensions to ensure the lock screw is seated below the extended tulip." ".Note: be sure the lock screw is fully seated and the rod is fully locked down." ".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
Event or Problem Description
Information received stated a surgical case was performed a few months back with reline mas reduction where one of the tabs did not break all the way off.Patient underwent a revision procedure.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9747532
• Report Number: 2031966-2020-00030
• Device Sequence Number: 2483081
• Product Code: NKB
• UDI-Device Identifier: 00887517655806
• UDI-Public: 887517655806
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 16191111
• 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: 01/27/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR