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

Model Number	13115535
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11464420
• Report Number: 2031966-2021-00039
• Device Sequence Number: 3522916
• Product Code: NKB
• UDI-Device Identifier: 00887517582201
• UDI-Public: 887517582201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: 13115535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention