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

Model Number 13066540

Device Problem Malposition of Device (2616)

Patient Problem Nerve Damage (1979)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

No product malfunction has been alleged.Though no malfunction was suggested an examination of the ex-planted device found no defects or malfunctions related to the reported event and found to meet all design specifications.No radiographs or images were provided so the breech could not be confirmed.Review of the reported event indicates a procedural error related to either an over sized implant selection or improper angulation during implantation may have contribute to alleged event.Labeling review: ".Ensure the k-wire is not advancing as the path is created over the k-wire.Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire." ".K-wire should be removed when screw has reached the posterior wall of the pedicle to avoid kink in tip." ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.".

Event Description

A patient underwent a posterior fixation procedure on (b)(6) 2020 at l4-5, levels.As per reporter the pedicle of left l5 level was breached by the tip of pedicle screw while the physician was inserting the screw.There was possibility to damage a nerve.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: 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: george panfili ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 9850924
• MDR Text Key: 187954049
• Report Number: 2031966-2020-00043
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517547989
• UDI-Public: 887517547989
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

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
• Device Operator: Health Professional
• Device Model Number: 13066540
• Device Lot Number: EM6784
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention