MAUDE Adverse Event Report: NUVASIVE NUVASIVE® RELINE® 4.5-5.0 SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	14514530
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation nor were radiographic images or bone quality test results provided to confirm the alleged event.At this time, the alleged event could not be confirmed.Insufficient information was provided to determine the root cause.Labeling review: potential adverse events and complications.".As with any major surgical procedures, there are risks involved in orthopedic surgery." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." 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.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components." post-operative warnings ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.".
Event or Problem Description
It was reported that a patient underwent a spine procedure.During a revision, the surgeon noticed that one screw had pulled out in the lumbar region (l4- right).The pulled out screw was replaced with no reported issue.As per reporter, the patient is currently doing well post-revision.The reason for the revision was not confirmed.

• Brand Name: NUVASIVE® RELINE® 4.5-5.0 SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8401953
• Report Number: 2031966-2019-00168
• Device Sequence Number: 2029734
• Product Code: NKB
• UDI-Device Identifier: 00887517767653
• UDI-Public: 887517767653
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K170126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: 14514530
• 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: 02/15/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1