MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE VUEPOINT OCT SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	8980014P3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation as no device malfunction has been alleged.No radiographic images were provided so the complaint was not confirmed.No patient bone quality report provided.No root cause can be confirmed at this time.Labeling review: ".Care should be used in the handling and storage of the implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.All non-sterile parts should be cleaned and sterilized before use.Devices should be inspected for damage prior to implantation.6.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Use of cross sectional imaging (i.E., ct and/or mri) 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.".
Event or Problem Description
On (b)(6) 2019 a patient underwent a spinal procedure at c4/6 levels as per reporter, the lateral mass was broken at right c6 while the physician was conducting the final tightening.The physician used lamina screw instead of poly axial screw.

• Brand Name: NUVASIVE VUEPOINT OCT SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 10139070
• Report Number: 2031966-2020-00124
• Device Sequence Number: 19673322
• Product Code: KWP
• UDI-Device Identifier: 00887517826343
• UDI-Public: 887517826343
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093319
• 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): 06/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 8980014P3
• Device Lot Number: SL0004
• 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: 09/10/2019
• Initial Report FDA Received Date: 06/10/2020
• 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: Other
• Patient Age: 69 YR