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

Model Number 16027550

Device Problems Decoupling (1145); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation, xray films provided confirm the alleged event.No root cause can be confirmed at this time.".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." ".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.Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.".

Event Description

On (b)(6) a patient underwent a posterior fixation procedure.During a post-op follow up, an x-ray discovered that a screw tulip had dissociation and the rod had slipped at s1 level.Patient underwent a revision procedure on (b)(6) 2020.Patient was reported as asymptomatic.

• 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: 10365831
• MDR Text Key: 203498689
• Report Number: 2031966-2020-00154
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517557001
• UDI-Public: 887517557001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16027550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• 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
• Patient Age: 76 YR
• Patient Weight: 95