MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE ACP HYBRID PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	18006236
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an initial three (3) level anterior cervical plate fixation procedure.Subsequently, a post-operative evaluation performed sixteen (16) months later identified both screws at the bottom level appeared to be backing out.There is no intent to revise the construct at this time.No further patient impact was reported.
Additional Manufacturer Narrative
The reported event was confirmed by review of the radiographic image provided.No product was returned to nuvasive for evaluation as the device remains in-situ.Further, operative notes and/or immediate post-op radiographs were not provided for review of usage/technique to determine if the screws were adequately seated and the construct was appropriately locked during the initial procedure.A definitive root cause was unable to be determined with the information provided.There are warnings in the device labeling that this type of event can occur: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Warnings, cautions and precautions: to allow for proper utility of the locking mechanism during screw placement, use a drill-guide with the awl and/or drill to create a centered screw hole into the vertebral bodies.Care should be taken to ensure that all components are ideally fixated prior to closure." ".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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information received subsequent to the initial medwatch submission.
Event or Problem Description
It was reported that the patient underwent an initial two (2) level anterior cervical plate fixation procedure.Subsequently, a post-operative evaluation performed approximately six (6) weeks later identified both screws at the bottom level appeared to be backing out.There is no intent to revise the construct at this time.No further patient impact was reported.

• Brand Name: NUVASIVE ACP HYBRID PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13896312
• Report Number: 2031966-2022-00064
• Device Sequence Number: 19804205
• Product Code: KWQ
• UDI-Device Identifier: 00195377009784
• UDI-Public: 195377009784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 18006236
• Device Catalogue Number: N/A
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACP SCREW, 3.5X15MM (QTY (B)(4)); ACP SCREW, 3.5X19MM (QTY (B)(4))
• Patient Sex: Prefer Not To Disclose