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

Model Number	16026550
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product malfunction was reported so no devices were returned for evaluation.No photographs or images have been provided so the complaint is unconfirmed.Review of the reported event describes how while the surgeon removed the tab for break off and experienced a slip of his hand, these tabs are known to be sharp and label warnings are present.The root cause of the issue is a procedural error related to the surgeon handling sharp extension tabs post break-off, which is the consequence of surgical technique.No additional investigation required.Labeling review: ".Warnings, cautions and precautions: the implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.All implants should be used only with the appropriately designated instrument (reference surgical technique).Be careful when palpating the break point as the tulip may be sharp.".
Event or Problem Description
On (b)(6) 2020 during a spinal procedure the surgeon moved the reduction tabs medial lateral in order to break off an implanted reduction screw.When doing this one of the distal tips of the reduction screw fractured off piece and cut the surgeon¿s skin across the finger on his left hand.No significant harm occurred.The surgeon unscrubbed, clean his hand with antiseptic, cover the cut with a sterile dressing & continue to operation.The cut was small but broke the skin.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15458144
• Report Number: 2031966-2022-00186
• Device Sequence Number: 6842176
• Product Code: NKB
• UDI-Device Identifier: 00887517556646
• UDI-Public: 887517556646
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 16026550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male