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

Model Number	16027550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation, nor were radiographs or images provided to confirm the alleged event.Root cause has not been determined at this time.Labeling review: preoperative warnings ".Care should be used in the handling and storage of the reline implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments." ".Devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device and injury to the patient." ".All implants should be used only with the appropriately designated instrument." ".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 (b)(6) 2019 a patient underwent a spinal procedure, post operative radiographs revealed a screw tab remained in situ.A revision procedure was conducted the same day and the tab was successfully removed.No patient injury reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego 92121
• MDR Report Key: 9099894
• Report Number: 2031966-2019-00237
• Device Sequence Number: 2665388
• Product Code: NKB
• UDI-Device Identifier: 00887517557001
• UDI-Public: 887517557001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16027550
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other