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

Model Number	10055445
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a patient underwent a posterior fixation procedure from l4 to l5.During the procedure while attempting to affix a cross connector the device locking cam appeared to be damaged.The surgeon attempted to remove the engaged driver but it was caught on the driver head and had to be forcibly removed breaking the implant.No patient injury or adverse consequences reported.
Additional Manufacturer Narrative
The device was return and photos were provided confirming the alleged complaint.No torque information could be provided and it is unknown of the surgeon utilized hand tightening.Review of the provided photographs found one of the lateral cams had disassociated from the connector with mal positioned rod contact marks additionally cams rotational marks are bent and flared suggesting excessive force.Review of the reported event identified lock damage incurred during attempted placement.Review of all information received indicates excessive force during lock initiation while incomplete rod engagement resulting in damage to the locking mechanism.No additional investigation necessary.Label review "warnings, cautions and precautions - cross connectors are designed specific to the rod diameter and cannot be used on the tapered section of tapered rods.If using cross connectors on tapered rods, only attach them on constant diameter rod sections.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 (reference surgical technique)." should not be scratched or damaged." ".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." #(b)(4).

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15712001
• Report Number: 2031966-2022-00237
• Device Sequence Number: 14735655
• Product Code: NKB
• UDI-Device Identifier: 00887517534705
• UDI-Public: 887517534705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/01/2022

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: 10055445
• Device Lot Number: N332546
• 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: 10/11/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: Female