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

Model Number	15355300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs or images provided to confirm the alleged event.It is unknown if patient followed post-operative restrictions and/or suffered a fall.Patient's bone quality is unknown.Labeling 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), loss of fixation, nonunion or delayed union, pain, discomfort or abnormal sensations due to the presence of the device." ".Warnings, cautions and precautions: internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ".Patient education:the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration well as to other complications.".
Event or Problem Description
As per report patient was experiencing pain and signs of screw loosening.On (b)(6) 2020, patient underwent a revision procedure where a broken rod identified.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10209128
• Report Number: 2031966-2020-00137
• Device Sequence Number: 2552617
• Product Code: NKB
• UDI-Device Identifier: 00887517509949
• UDI-Public: 887517509949
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15355300
• 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: 06/04/2020
• Initial Report FDA Received Date: 06/29/2020
• 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
• Patient Weight: 105