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

Model Number 13116545

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for investigation as no product malfunction has been reported.No radiographs were provided to confirm the alleged event.Information received indicates operator misplacement may have contributed to alleged event.Labeling review: ".Place the patient on the operating table in a prone position prepare and drape in a conventional manner.The fluoroscope should have easy access to the surgical field for both a/p and lateral views.Uniplanar or biplanar fluoroscopy may be used.".

Event Description

On (b)(6) 2018, patient underwent an extreme lateral interbody fusion procedure and posterior fixation on (b)(6) 2018 at levels l2-l5 with no reported issues.Post-operative examination found the right side screw at the l5 level was place inside-out instead of the intended outside-in.On (b)(6) 2018 a revision procedure was performed replacing and redirecting the screw.No alleged product malfunction reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 7803931
• MDR Text Key: 117828875
• Report Number: 2031966-2018-00131
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517582508
• UDI-Public: 00887517582508
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143684
• 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: 08/21/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 13116545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/21/2018
• 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