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

Model Number	16191111
Medical Device Problem Codes	Break (1069); Misassembled During Installation (4049)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation as it remains in-situ.Radiographs provided confirm the alleged event.Labeling review: ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument." ".Preoperative 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 (fig.12).Note: be sure the lock screw is fully seated and the rod is fully reduced prior to breaking off the reduction extensions.".
Event or Problem Description
On an unknown date a patient underwent a posterior procedure at l4-s1 without any reported incidents.During a postoperative visit the reduction extension tabs were discovered still in-situ.No revision procedure is currently planned.
Event or Problem Description
Supplemental report submitted.
Additional Manufacturer Narrative
Review of the reported event describes the reduction tab fractured off above the desired location and the tab comparison process outlined in the instructions for use was not completed resulting in the fractured tab being left in-situ.Surgeons perogative was not to revise and leave as is.No additional investigation required.Labeling review: "note: be sure the lock screw is fully seated and the rod is fully locked down.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9703324
• Report Number: 2031966-2020-00027
• Device Sequence Number: 2824710
• Product Code: NKB
• UDI-Device Identifier: 00887517655806
• UDI-Public: 887517655806
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 11/05/2020

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
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR