MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE PRECEPT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8800000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

No device has been returned for evaluation nor have radiographs or images provided to confirmed the alleged malfunction.Label review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Failure to final-tighten the lock screws with the counter-torque and torque t-handle may result in rod not able to normalize to the tulip.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".Failure to verify screw height following insertion may result in screw heights not matching lordosis of the patient.All heights of screws should match with patient¿s lordosis to facilitate the best rod normalization when securing lock screws.".

Event Description

On an unknown date a patient underwent a single level posterior fixation procedure with no reported issues.Post-operative, a set screw was identified as detached.On (b)(6) 2020 a revision procedure took place.No patient injury reported.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 9794715
• MDR Text Key: 183100529
• Report Number: 2031966-2020-00034
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 887517344076
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8800000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1