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

Model Number	10060445
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two (2) cross-connectors were returned to nuvasive.It is unknown which device malfunctioned intra-operatively.Lot number n268872 or n221994.Device msep (b)(6) 2020 or (b)(6) 2018 the complaint devices, two (2) cross-connectors and one (1) 40in-lb torque handle, were evaluated and the reported event was confirmed.The evaluation identified that the locking cams on both connectors exhibited severe deformation to the hexalobe drive features as well as dislocation of the cam component in the arm assemblies.It could not be determined if the damage occurred during the reported locking failure of the device or during removal.However, the torque handle used with the fractured driver was determined to be damaged and out of calibration, allowing excessive torque force to be applied.A review of the device history records was performed and no discrepancies were found.The cause of the device failures was determined to likely be excessive force applied by the damaged handle.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra." ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that that patient underwent an initial posterior fixation procedure.During the procedure, as the surgeon attempted to tighten the locking cam of the cross connector on the rod, the cam spun and was unable to be tightened.Subsequently, the surgeon encountered difficulties in removal of the connector and had to use a leskal to rip the device out of the construct, resulting in a broken pedicle.As a result, the fusion had to be extended.No further patient impact was reported.

• Brand Name: NUVASIVE RELINE OPEN SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15442596
• Report Number: 2031966-2022-00183
• Device Sequence Number: 5569737
• Product Code: NKB
• UDI-Device Identifier: 00887517535078
• UDI-Public: 887517535078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10060445
• Device Catalogue Number: N/A
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• 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: 04/16/2021
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TORQUE HANDLE, 40 IN-LB
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose