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

Model Number 13115535

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pneumothorax (2012)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

No radiographs were provided for review.No device was returned as the device was not believed at fault in the event.Review of surgeons notes identified he made a mis-selection of the screw length and had an error in creating the pilot hole.The patient has recovered from pneumothorax and is doing well.".Potential risks identified with the use of this system, which may require additional surgery, include:.Neurological, vascular or visceral injury ¿" ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.".

Event Description

On (b)(6) 2021 a male patient underwent a spinal procedure.During the procedure it was reported that a pedicle screw penetrated the anterior wall of the vertebral body at right th3 and contacted the patients lungs, resulting in pneumothorax.The screw was removed and the physician installed a chest tube and resumed the operation.The surgeon believed he made a mis-selection of the screw length and had an error in creating the pilot hole.The patient has recovered from pneumothorax and is doing well.

• 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: dean lucas ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 11464420
• MDR Text Key: 239695693
• Report Number: 2031966-2021-00039
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517582201
• UDI-Public: 887517582201
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 13115535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention