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

Model Number	8970000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2021 a patient underwent a cervical posterior fixation procedure from o-c2.The surgery was completed without issue.On (b)(6)2022 it was discovered the right screw at c2 had loosened and the set screw in the left c2 had backed out.The patient was asymptomatic and their post op activity levels could not be confirmed.On (b)(6)2022 a revision surgery occurred where the right loosened pedicle screw and the backed out set screw where replaced.The patient continues to remain asymptomatic post revision.
Additional Manufacturer Narrative
The device was returned and the complaint was confirmed.The patients post op activity levels could not be confirmed or whether fusion was achieved.Examination of the returned lock screw was found damage consistent with rod reduction/normalization interference during lock screw initiation deterring full lock down leading to the subsequent lock screw back out.No additional investigation required.Label 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." " potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." " if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." "care should be taken to insure that all components are ideally fixated prior to closure." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." "post-operative warnings; during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." #(b)(4).

• Brand Name: NUVASIVE VUEPOINT OCT SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15261820
• Report Number: 2031966-2022-00153
• Device Sequence Number: 6663938
• Product Code: KWP
• UDI-Device Identifier: 00887517397133
• UDI-Public: 887517397133
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8970000
• Device Lot Number: NU18000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male