MAUDE Adverse Event Report: STRYKER SPINE-US AVIATOR ASSY THREE LEVEL PLATE SIZE 39; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48811339
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was confirmed via x-ray that an aviator screw backed-out of an aviator 3-level plate with a deformed locking mechanism post-operatively.The patient has been revised, the screw was removed while the plate remains implanted.This record represents the plate.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, x-ray imaging was provided showing that one of the screws migrated out of the plate post-operatively.A review of the device history and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: use of the screw hole preparation instruments including the fixed or variable drill guides, all-in-one drill guides or punch awl with sleeves is required to place screws in the proper trajectory, help prevent damage to implants, difficulty locking the blocker, or locking mechanism malfunction.If self-drilling screws are used, use either the punch awl with a sleeve or a drill bit and drill guide to center and direct the pathway of the screw.Note: using the punch awl is strongly recommended when self-drilling screws are used, as it helps to provide an optimal screw trajectory.Do not cantilever the guide during removal from plate as it can damage locking mechanism.When screws are fully inserted within the allowed range of angulation, the spring bar can then expand over the screw head.The procedure will not restore function to the level expected with a normal, healthy spine, and surgeons should counsel patient to not have unrealistic functional expectations.Patients who smoke have been shown to have an increased incidence of non-unions.Such patients must be advised of this fact and warned of the potential consequences.Per the surgical technique guide, the aviator system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions.The patient fused therefore implant fulfilled its intended use.
Event or Problem Description
It was confirmed via x-ray that an aviator screw backed-out of an aviator 3-level plate with a deformed locking mechanism post-operatively.The patient has been revised, the screw was removed while the plate remains implanted.This record represents the plate.

• Brand Name: AVIATOR ASSY THREE LEVEL PLATE SIZE 39
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9656247
• Report Number: 0009617544-2020-00013
• Device Sequence Number: 16703104
• Product Code: KWQ
• UDI-Device Identifier: 07613252152262
• UDI-Public: 07613252152262
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48811339
• Device Catalogue Number: 48811339
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 02/01/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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: Required Intervention