MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE VUEPOINT II OCT SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	8980130P3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product returned for evaluation nor radiographs or images provided to confirm the alleged event.No allegation of product malfunction was reported.A review of the reported statement suggests implant selection and or placement may have caused or contributed to the reported event.Labeling review: ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." ".Use of cross sectional imaging for posterior cervical screw placement is recommended due to the unique risks in the cervical spine.The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement.In addition use of intraoperative imaging should be considered to guide and or verify device placement as necessary." no product returned.
Event or Problem Description
On (b)(6) 2019 patient underwent a cervical procedure at c2 to c7 levels without reported issues.Post operatively a pedicle breach at c7 left side was identified.On (b)(6) 2019 a revision procedure was completed removing the screw at c7 and extending the fixation to t2.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8966864
• Report Number: 2031966-2019-00234
• Device Sequence Number: 19370879
• Product Code: NKG
• UDI-Device Identifier: 00887517826640
• UDI-Public: 887517826640
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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: 8980130P3
• 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: 08/09/2019
• Initial Report FDA Received Date: 09/05/2019
• 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 Age: 72 YR