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

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction was alleged.No radiographs were provided to confirm the alleged event.Literature review: 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." ".Pain, discomfort or abnormal sensations due to the presence of the device.".

Event Description

Patient underwent a spinal procedure at th9/il with reline on (b)(6) 2020.As per reporter, patient was experiencing pain in leg, and a revision procedure was performed on (b)(6) 2020.During the revision procedure a pedicle screw at right l5 was replaced as the tip of screw was positioned too medial.No other patient complications were reported.

Manufacturer Narrative

Eventhough root cause cannot be confirmed, the review of the reported event identified the surgeon implanted screw was positioned too medial during the index procedure.Labeling review: warnings, cautions and precautions the implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Preoperative warnings 6.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Type of Device: NUVASIVE RELINE SYSTEM
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 10084287
• MDR Text Key: 193398459
• Report Number: 2031966-2020-00089
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K190636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 04/27/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR