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

Model Number	13116545
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7803931
• Report Number: 2031966-2018-00131
• Device Sequence Number: 19454965
• Product Code: NKB
• UDI-Device Identifier: 00887517582508
• UDI-Public: 00887517582508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 13116545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1