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

Model Number 8848160006

Device Problem Misassembled During Installation (4049)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation and no radiographs could be provided confirming the event.Review of the provided information suggests the root cause of the issue is user error during installation as it was admitted that the device was misassembled during installation.No additional investigation can be completed."potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include.Potential risks identified with the use of this system, which may require additional surgery, include:.Bending, fracture or loosening of implant component(s).Loss of fixation." ".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.".

Event Description

On (b)(6) 2021 a patient underwent a posterior fixation procedure.In (b)(6) on a unknown date during a routine post op follow up a radiograph revealed that the that the rod was installed in reverse against the curvature, causing the screw loosening.On (b)(6)2021 a revision occurred where the loose screw was replaced with a new screw, and the fixation level was extended one vertebra to the cranial side.Reportedly the operation was successfully completed and the patient has been recovering.

• Brand Name: NUVASIVE PRECEPT SPINAL 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: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 12318962
• MDR Text Key: 266639245
• Report Number: 2031966-2021-00095
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517314604
• UDI-Public: 887517314604
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171894
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8848160006
• Device Lot Number: CT5156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2021
• 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